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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 K031286
Device Name SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE
Applicant
Aesculap, Inc.
3773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact GEORG KELLER
Correspondent
Aesculap, Inc.
3773 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact GEORG KELLER
Regulation Number878.4493
Classification Product Code
GAM  
Date Received04/23/2003
Decision Date 05/29/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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