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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
510(k) Number K163049
Device Name GOLNIT Non-Absorbable PTFE Surgical Suture
Applicant
Antarma Dba Golnit Sutures
1204 Ave. U, #2030
Brooklyn,  NY  11229
Applicant Contact Armine Badalyan
Correspondent
Antarma Dba Golnit Sutures
1204 Ave. U, #2030
Brooklyn,  NY  11229
Correspondent Contact Armine Badalyan
Regulation Number878.5035
Classification Product Code
NBY  
Date Received11/01/2016
Decision Date 06/21/2017
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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