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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 K992088
Device Name BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
Applicant
Genzyme Surgical Product (Genzyme Biosurgery)
600 Airport Rd.
Fall River,  MA  02720
Applicant Contact MARY E GRAY
Correspondent
Genzyme Surgical Product (Genzyme Biosurgery)
600 Airport Rd.
Fall River,  MA  02720
Correspondent Contact MARY E GRAY
Regulation Number878.4493
Classification Product Code
GAM  
Date Received06/21/1999
Decision Date 09/03/1999
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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