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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.
3773 CORPORATE PARKWAY
CENTER VALLEY,  PA  18034
Applicant Contact KATHY A. RACOSKY
Correspondent
AESCULAP, INC.
3773 CORPORATE PARKWAY
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
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