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 |