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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 K945231
Device Name SELF-LATCHING CLIP
Applicant
SURGICAL SYSTEM, INC.
9 YALE DR.
SUCCASUNNA,  NJ  07876
Applicant Contact FRANK V GATES
Correspondent
SURGICAL SYSTEM, INC.
9 YALE DR.
SUCCASUNNA,  NJ  07876
Correspondent Contact FRANK V GATES
Regulation Number878.4300
Classification Product Code
FZP  
Date Received10/27/1994
Decision Date 01/27/1995
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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