SinuBand
Splint, Intranasal Septal
BIOINSPIRE TECHNOLOGIES, INCORPORATED
The following data is part of a premarket notification filed by Bioinspire Technologies, Incorporated with the FDA for Sinuband.
Pre-market Notification Details
| Device ID | K160101 |
| 510k Number | K160101 |
| Device Name: | SinuBand |
| Classification | Splint, Intranasal Septal |
| Applicant | BIOINSPIRE TECHNOLOGIES, INCORPORATED 2450 EMBARCADERO WAY Palo Alto, CA 94303 -3313 |
| Contact | Dorna Hakimimehr |
| Correspondent | Margaret Dillon BIOINSPIRE TECHNOLOGIES, INCORPORATED 2468 EMBARCADERO WAY Palo Alto, CA 94303 -3313 |
| Product Code | LYA |
| CFR Regulation Number | 874.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-19 |
| Decision Date | 2016-07-27 |
| Summary: | summary |
Trademark Results [SinuBand]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SINUBAND 87041743 not registered Dead/Abandoned |
BioInspire Technologies Inc 2016-05-18 |
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