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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name patch, pledget and intracardiac, petp, ptfe, polypropylene
510(k) Number K001785
Device Name SURGISIS PERIPHERAL VASCULAR PATCH
Applicant
COOK BIOTECH, INC.
3055 KENT AVE.
WEST LAFAYETTE,  IN  47906 -1076
Applicant Contact NEAL E FEARNOT
Correspondent
COOK BIOTECH, INC.
3055 KENT AVE.
WEST LAFAYETTE,  IN  47906 -1076
Correspondent Contact NEAL E FEARNOT
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received06/13/2000
Decision Date 12/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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