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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, absorbable, synthetic, polyglycolic acid
510(k) Number K991191
Device Name BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
Applicant
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
600 AIRPORT RD.
FALL RIVER,  MA  02720 -4740
Applicant Contact MARY E GRAY
Correspondent
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
600 AIRPORT RD.
FALL RIVER,  MA  02720 -4740
Correspondent Contact MARY E GRAY
Regulation Number878.4493
Classification Product Code
GAM  
Date Received04/08/1999
Decision Date 06/22/1999
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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