The following data is part of a premarket notification filed by Innovative Surgical Solutions, Llc ("iss") with the FDA for Neuralmas.
| Device ID | K100992 |
| 510k Number | K100992 |
| Device Name: | NEURALMAS |
| Classification | Stimulator, Nerve |
| Applicant | INNOVATIVE SURGICAL SOLUTIONS, LLC ("ISS") 55 NORTHERN BLVD SUITE 200 Great Neck, NY 10021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk INNOVATIVE SURGICAL SOLUTIONS, LLC ("ISS") 55 NORTHERN BLVD SUITE 200 Great Neck, NY 10021 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-09 |
| Decision Date | 2010-09-24 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NEURALMAS 85170500 not registered Dead/Abandoned |
Innovative Surgical Solutions, LLC 2010-11-05 |