Neurosplint
Orthosis, Limb Brace
Neurospectrum LLC
The following data is part of a premarket notification filed by Neurospectrum Llc with the FDA for Neurosplint.
Pre-market Notification Details
| Device ID | K143458 |
| 510k Number | K143458 |
| Device Name: | Neurosplint |
| Classification | Orthosis, Limb Brace |
| Applicant | Neurospectrum LLC 3 Crown Crt Rancho Mirage, CA 92270 |
| Contact | David Kernan |
| Correspondent | Jean Bigoney Nu Device Consulting LLC 27 Redstone Rd Newport, NH 03773 |
| Product Code | IQI |
| CFR Regulation Number | 890.3475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-04 |
| Decision Date | 2015-08-13 |
Trademark Results [Neurosplint]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEUROSPLINT 86339995 not registered Dead/Abandoned |
NEUROSPECTRUM, LLC 2014-07-17 |
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