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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 K993785
Device Name ULTRACLIP TISSUE MARKER
Applicant
INRAD
3956 44TH ST., S.E.
KENTWOOD,  MI  49512
Applicant Contact JOSEPH M MAZUREK
Correspondent
INRAD
3956 44TH ST., S.E.
KENTWOOD,  MI  49512
Correspondent Contact JOSEPH M MAZUREK
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
FZP  
Date Received11/08/1999
Decision Date 02/04/2000
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
Recalls CDRH Recalls
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