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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 K905482
Device Name BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE
Applicant
Pfizer Hospital Products Group, Inc.
600 Airport Rd.
Fall River,  MA  02722
Applicant Contact MICHAEL SANTALUCIA
Correspondent
Pfizer Hospital Products Group, Inc.
600 Airport Rd.
Fall River,  MA  02722
Correspondent Contact MICHAEL SANTALUCIA
Regulation Number878.4493
Classification Product Code
GAM  
Date Received12/06/1990
Decision Date 03/14/1991
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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