FDA 510(k) Applications for Medical Device:
Dialyzer Reprocessing System

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K013713 ALCAVIS INTERNATIONAL INCORPORATED 8-8 METROPOLITAN CT.
GAITHERSBURG MD 20878
K043126 ALCAVIS INTERNATIONAL, INC. 8-8 METROPOLITAN CT.
GAITHERSBURG MD 20878
K853413 ALCIDE CORP. ONE WILLARD RD.
NORWALK CT 06851
K970799 ALEXANDER MFG. CO. 1511 S GARFIELD PL
MASON CITY IA 50401
K992016 AMUCHINA INTL., INC. 8-8 METROPOLITAN CT.
GAITHERSBURG MD 20878
K874034 BIODYNAMICS CORP. 6611 PORTWEST DR.
HOUSTON TX 77024
K833128 CHEMICAL DETECTION & EXPERIMENTATION
K853817 COBE LABORATORIES, INC. 1185 OAK ST.
LAKEWOOD CO 80215
K841153 COLORADO MEDICAL, INC.
K830190 COLORADO MEDICAL, INC.
K870689 COLORADO MEDICAL, INC. BERGEN PARK BUSINESS PLAZA
EVERGREEN CO 80439
K870471 COLORADO MEDICAL, INC. BERGEN PARK BUSINESS PLAZA
EVERGREEN CO 80439
K813107 COMPUTER DIALYSIS SYSTEMS, INC.
K831132 COMPUTER DIALYSIS SYSTEMS, INC.
K850127 COMPUTER DIALYSIS SYSTEMS, INC.
BOULDER CO 80301
K905217 DI-CHEM, INC. 10550 COUNTY RD. 81
MAPLE GROVE MN 55369
K974798 ENVIRONMENTAL TEST SYSTEMS, INC. 23575 COUNTY RD., #106
ELKHART IN 46514
K944492 G.E.M. WATER SYSTEMS 5940 LAKESHORE DR.
CYPRESS CA 90630
K040660 HACH COMPANY 23575 COUNTY ROAD 106
ELKHART IN 46514
K024076 HDC MAQUINOLAS, LLC 8508 BEACON BEND LN.
PEARLAND TX 77584
K850799 MEDICAL TECHNOLOGIES INTERNATIONAL, INC. 3922 NORTH SAGIHAW ST.
FLINT MI MI 48505
K832705 MEDICORP, INC. 240 WEST 2950 SOUTH
SALT LAKE CITY UT 84115
K860026 MEDICORP, INC. 230 WEST 2950 SOUTH
SALT LAKE CITY UT 84115
K834447 MESA MEDICAL, INC.
K821383 MESA MEDICAL, INC.
K843520 MESA MEDICAL, INC.
K033505 MINNTECH CORP. 14605 28TH AVE. NORTH
MINNEAPOLIS MN 55447
K991851 MINNTECH CORP. 14605 28TH AVE. NORTH
MINNEAPOLIS MN 55447
K904210 MINNTECH CORP. 14605 28TH AVE. NORTH
MINNEAPOLIS MN 55447
K941757 NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. RESERVOIR PLACE
WALTHAM MA 02154
K091360 NOVAFLUX TECHNOLOGIES 1 WALL STREET
PRINCETON NJ 08540
K941867 RENAL SCIENTIFIC SERVICE, INC. RESERVIOR PLACE
WALTHAM MA 02145
K833181 RENAL SYSTEMS, INC.
K820221 RENAL SYSTEMS, INC.
K812230 RENAL SYSTEMS, INC.
K830575 RENAL SYSTEMS, INC.
K842258 RENAL SYSTEMS, INC.
K830574 RENAL SYSTEMS, INC.
K974426 REPROCESSING PRODUCTS CORP. 8662 COMSTOCK LN.
MAPLE GROVE MN 55311
K832230 SERATRONICS, INC.
K821863 SERATRONICS, INC.
K923529 SERATRONICS, INC. 2637 SHADELANDS DR.
WALNUT CREEK CA 94598
K955299 SERATRONICS, INC. 2637 SHADELANDS DR.
WALNUT CREEK CA 94598
K931336 SERATRONICS, INC. 2637 SHADELANDS DR.
WALNUT CREEK CA 94598
K944539 SERATRONICS, INC. 2637 SHADELANDS DR.
WALNUT CREEK CA 94598
K914580 SERATRONICS, INC. 4090 PIKE LN.
CONCORD CA 94520
K860674 SERATRONICS, INC. 4090 PIKE LN.
CONCORD CA 94520
K874573 SERATRONICS, INC. 4090 PIKE LN.
CONCORD CA 94520
K911628 SERIM RESEARCH CORP. P.O. BOX 4002
ELKHART IN 46514 0002
K911629 SERIM RESEARCH CORP. P.O. BOX 4002
ELKHART IN 46514 0002
K902227 SERIM RESEARCH CORP. P.O. BOX 4002
ELKHART IN 46514 0002
K914123 SERIM RESEARCH CORP. P.O. BOX 4002
ELKHART IN 46514 0002
K900341 SERIM RESEARCH CORP. P.O. BOX 4002
ELKHART IN 46514 0002
K830722 SPORICIDIN INTL.
K820695 TEXAS MEDICAL DEVICES, INC.
K884154 THOMAS J. FOGARTY, M.D. 770 WELCH RD.
PALO ALTO CA 94304
K802828 UNITED MEDICAL
K830557 UNIVERSO S.A.




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