ChitoZolve
Splint, Intranasal Septal
Gyrus ACMI, Inc
The following data is part of a premarket notification filed by Gyrus Acmi, Inc with the FDA for Chitozolve.
Pre-market Notification Details
| Device ID | K181696 |
| 510k Number | K181696 |
| Device Name: | ChitoZolve |
| Classification | Splint, Intranasal Septal |
| Applicant | Gyrus ACMI, Inc 136 Turnpike Road Southborough, MA 01772 |
| Contact | Dolan Mills |
| Correspondent | Dolan Mills Gyrus ACMI, Inc 136 Turnpike Road Southborough, MA 01772 |
| Product Code | LYA |
| CFR Regulation Number | 874.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-27 |
| Decision Date | 2018-11-30 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925044166 | K181696 | 000 |
Trademark Results [ChitoZolve]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CHITOZOLVE 88048174 5789572 Live/Registered |
OLYMPUS CORPORATION 2018-07-23 |
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