FDA 510(k) Application Details - K915591

Device Classification Name Gauze/Sponge,Nonresorbable For External Use

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510(K) Number K915591
Device Name Gauze/Sponge,Nonresorbable For External Use
Applicant EAGLE MEDICAL, INC.
160 CORPORATE WOODS COURT
P.O. BOX 640
BRIDGETON, MO US
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Contact ARNOLD LERMAN
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Regulation Number 878.4014

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Classification Product Code NAB
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Date Received 12/13/1991
Decision Date 01/27/1993
Decision SE - Substantially Equivalent
Classification Advisory Committee HO - General Hospital
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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