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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 K212888
Device Name Golnit Nylon Monofilament Suture
Applicant
Antarma LLC dba Golnit Sutures
276 5th Ave., Suite 704
New York,  NY  10001
Applicant Contact Armine Badalyan
Correspondent
Antarma LLC dba Golnit Sutures
276 5th Ave., Suite 704
New York,  NY  10001
Correspondent Contact Armine Badalyan
Regulation Number878.5020
Classification Product Code
GAR  
Date Received09/10/2021
Decision Date 03/31/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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