The following data is part of a premarket notification filed by Chitogel Ltd with the FDA for Chitogel Endoscopic Sinus Surgery Kit.
| Device ID | K172179 |
| 510k Number | K172179 |
| Device Name: | Chitogel Endoscopic Sinus Surgery Kit |
| Classification | Splint, Intranasal Septal |
| Applicant | Chitogel Ltd 139 Moray Place Dunedin, NZ 9016 |
| Contact | Caty Spencer |
| Correspondent | Gregory Mathison Regulatory Strategies, Inc 3924 Cascade Beach Road Lutsen, MN 55612 |
| Product Code | LYA |
| CFR Regulation Number | 874.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-19 |
| Decision Date | 2017-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09400998100040 | K172179 | 000 |