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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clip, implantable
510(k) Number K911915
Device Name HEMOCLIP II
Applicant
EDWARD WECK, INC.
P.O. BOX 12600
WECK DRIVE
RESEARCH TRIANGLE PA,  NC  27709
Applicant Contact GLENN M MATTEI
Correspondent
EDWARD WECK, INC.
P.O. BOX 12600
WECK DRIVE
RESEARCH TRIANGLE PA,  NC  27709
Correspondent Contact GLENN M MATTEI
Regulation Number878.4300
Classification Product Code
FZP  
Date Received04/30/1991
Decision Date 01/09/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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