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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 K944937
Device Name SYNTHETIC ABSORBABLE SUTURE
Applicant
Johnson & Johnson International
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact SALLY L MAHER
Correspondent
Johnson & Johnson International
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact SALLY L MAHER
Regulation Number878.4493
Classification Product Code
GAM  
Date Received10/06/1994
Decision Date 05/19/1995
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
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