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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 K913411
Device Name DAVIS & GECK VALTRAC(R) BIOFRAG ANASTOMOSIS RING
Applicant
DAVIS & GECK, INC.
AMERICAN CYNAMID COMPANY
ONE CASPER STREET
DANBURY,  CT  06810
Applicant Contact TAMSETT
Correspondent
DAVIS & GECK, INC.
AMERICAN CYNAMID COMPANY
ONE CASPER STREET
DANBURY,  CT  06810
Correspondent Contact TAMSETT
Regulation Number878.4750
Classification Product Code
GDW  
Date Received07/31/1991
Decision Date 09/06/1991
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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