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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 K896997
Device Name ATRAUCLIP (TITANIUM HEMOSTATIC CLIP)
Original Applicant
S.P.K. TECHNOLOGY, INC.
321 regatta way
seal beach,  CA  90740
Original Contact john j malloy
Regulation Number878.4300
Classification Product Code
FZP  
Date Received12/12/1989
Decision Date 02/13/1990
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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