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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polyamide
510(k) Number K151165
Device Name Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture
Applicant
Aesculap, Inc.
3 773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact KATHY A. RACOSKY
Correspondent
Aesculap, Inc.
3 773 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact KATHY A. RACOSKY
Regulation Number878.5020
Classification Product Code
GAR  
Date Received05/01/2015
Decision Date 02/17/2016
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
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