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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 K953258
Device Name TITANIUM HEMOSTATIC CLIP
Applicant
INTRAMED LABORATORIES, INC.
11100 ROSELLE ST.
SAN DIEGO,  CA  92121
Applicant Contact R. ALDEN KAY
Correspondent
INTRAMED LABORATORIES, INC.
11100 ROSELLE ST.
SAN DIEGO,  CA  92121
Correspondent Contact R. ALDEN KAY
Regulation Number878.4300
Classification Product Code
FZP  
Date Received07/12/1995
Decision Date 01/05/1996
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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