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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, Polypropylene
510(k) Number K180321
Device Name Aesculap Optilene Nonabsorbable 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 Number878.5010
Classification Product Code
GAW  
Date Received02/05/2018
Decision Date 03/07/2018
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
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