Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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 No. 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 No. 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
-
-