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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, Silk
510(k) Number K172149
Device Name FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture
Applicant
M/s. Meril Endo Surgery Private Limited.
Third Floor, E1-E3, Meril Park, Survey # 135/2/B & 174/2,
Muktanand Marg
Chala, Vapi,  IN 396191
Applicant Contact Umesh Sharma
Correspondent
M/s. Meril Endo Surgery Private Limited.
Third Floor, E1-E3, Meril Park, Survey # 135/2/B & 174/2,
Muktanand Marg
Chala, Vapi,  IN 396191
Correspondent Contact Umesh Sharma
Regulation Number878.5030
Classification Product Code
GAP  
Subsequent Product Codes
GAR   GAT   GAW  
Date Received07/17/2017
Decision Date 10/20/2017
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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