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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name applier, surgical, clip
510(k) Number K926199
Device Name UNICLIP SURGICAL CLIP APPLIER
Applicant
UNISURGE, INC.
10231 BUBB RD.
CUPERTINO,  CA  95014
Applicant Contact V, JOHNSON
Correspondent
UNISURGE, INC.
10231 BUBB RD.
CUPERTINO,  CA  95014
Correspondent Contact V, JOHNSON
Regulation Number878.4800
Classification Product Code
GDO  
Date Received12/09/1992
Decision Date 04/20/1993
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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