The following data is part of a premarket notification filed by M/s. Meril Life Sciences Private Limited with the FDA for Mesire - Balloon Sinus Dilatation System.
| Device ID | K172737 |
| 510k Number | K172737 |
| Device Name: | MESIRE - Balloon Sinus Dilatation System |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | M/s. Meril Life Sciences Private Limited Survey No. 135/139, Bilakhia House, Muktanand Marg Chala, Vapi, IN 396191 |
| Contact | Umesh Sharma |
| Correspondent | Umesh Sharma M/s. Meril Life Sciences Private Limited Survey No. 135/139, Bilakhia House, Muktanand Marg Chala, Vapi, IN 396191 |
| Product Code | LRC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-11 |
| Decision Date | 2017-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18904224905709 | K172737 | 000 |
| 18904224901473 | K172737 | 000 |
| 18904224901480 | K172737 | 000 |
| 18904224901497 | K172737 | 000 |
| 18904224901503 | K172737 | 000 |
| 18904224901510 | K172737 | 000 |
| 18904224901527 | K172737 | 000 |
| 18904224901534 | K172737 | 000 |
| 18904224901541 | K172737 | 000 |
| 18904224901466 | K172737 | 000 |