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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 K931056
Device Name DAVIS+GECK VALTRAC BIOFRAG ANASTOMOSIS RING
Applicant
AMERICAN CYANAMID CO.
ONE CASPER ST.
DANBURY,  CT  06810
Applicant Contact TAMSETT
Correspondent
AMERICAN CYANAMID CO.
ONE CASPER ST.
DANBURY,  CT  06810
Correspondent Contact TAMSETT
Regulation Number878.4750
Classification Product Code
GDW  
Date Received03/01/1993
Decision Date 07/08/1993
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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