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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 K192953
Device Name APTOS Threads – Polypropylene Surgical Sutures
Applicant
Aptos, LLC
20/4 V. Orbeliani St.
Tbilisi,  GE 0105
Applicant Contact Nikolai Pirtskhalaichvili
Correspondent
Aptos, LLC
20/4 V. Orbeliani St.
Tbilisi,  GE 0105
Correspondent Contact Nikolai Pirtskhalaichvili
Regulation Number878.5010
Classification Product Code
GAW  
Date Received10/21/2019
Decision Date 08/27/2020
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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