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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name staple, implantable
510(k) Number K970817
Device Name MICROMARK CLIP
Applicant
BIOPSYS MEDICAL, INC.
3 MORGAN
IRVINE,  CA  92618
Applicant Contact MARK A COLE
Correspondent
BIOPSYS MEDICAL, INC.
3 MORGAN
IRVINE,  CA  92618
Correspondent Contact MARK A COLE
Regulation Number878.4750
Classification Product Code
GDW  
Date Received03/06/1997
Decision Date 09/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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