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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 K943159
Device Name LIFE CLIP AND LIFE CLIP APPLIER
Applicant
LIFE SURGERY, INC.
329 WEST LINCOLN ST.
TULLAHOMA,  TN  37388
Applicant Contact JOHN I SHIPP
Correspondent
LIFE SURGERY, INC.
329 WEST LINCOLN ST.
TULLAHOMA,  TN  37388
Correspondent Contact JOHN I SHIPP
Regulation Number878.4300
Classification Product Code
FZP  
Subsequent Product Code
GCJ  
Date Received07/01/1994
Decision Date 08/16/1994
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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