The following data is part of a premarket notification filed by M/s. Meril Endo Surgery Private Limited with the FDA for Meristeel.
| Device ID | K172146 |
| 510k Number | K172146 |
| Device Name: | MERISTEEL |
| Classification | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| 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 |
| Contact | Umesh Sharma |
| Correspondent | Umesh Sharma 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 |
| Product Code | GAQ |
| CFR Regulation Number | 878.4495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-17 |
| Decision Date | 2018-02-01 |
| Summary: | summary |