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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, nonabsorbable, synthetic, polypropylene
510(k) Number K930587
Device Name SURGILENE POLYPROPYLENE SUTURE
Applicant
DAVIS & GECK, INC.
AMERICAN CYNAMID COMPANY
ONE CASPER STREET
DANBURY,  CT  06810
Applicant Contact JOHN SCHAEFER
Correspondent
DAVIS & GECK, INC.
AMERICAN CYNAMID COMPANY
ONE CASPER STREET
DANBURY,  CT  06810
Correspondent Contact JOHN SCHAEFER
Regulation Number878.5010
Classification Product Code
GAW  
Date Received02/04/1993
Decision Date 12/17/1993
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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