FDA 510(k) Application Details - K944968

Device Classification Name Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

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510(K) Number K944968
Device Name Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant MENLO CARE, INC.
1350 WILLOW RD.
MENLO PARK, CA US
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Contact THOM LAWSON
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Regulation Number 880.5200

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Classification Product Code FOZ
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Date Received 10/11/1994
Decision Date 03/29/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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