The following data is part of a premarket notification filed by M/s. Meril Endo Surgery Private Limited with the FDA for 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.
| Device ID | K160623 |
| 510k Number | K160623 |
| 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 |
| Classification | Suture, Nonabsorbable, Silk |
| Applicant | M/S. MERIL ENDO SURGERY PRIVATE LIMITED 3FL, E1-E3, MERIL PARK, SURVEY NO. 135/2/B & 174/2, MUKTANAND MARG Chala, Vapi, IN 396191 |
| Contact | Umesh Sharma |
| Correspondent | Umesh Sharma M/S. MERIL ENDO SURGERY PRIVATE LIMITED 3FL, E1-E3, MERIL PARK, SURVEY NO. 135/2/B & 174/2, MUKTANAND MARG Chala, Vapi, IN 396191 |
| Product Code | GAP |
| Subsequent Product Code | GAR |
| Subsequent Product Code | GAT |
| Subsequent Product Code | GAW |
| CFR Regulation Number | 878.5030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-04 |
| Decision Date | 2016-05-31 |
| Summary: | summary |