The following data is part of a premarket notification filed by Innovative Surgical Solutions, Llc ("iss") with the FDA for Sentio Mmg.
Device ID | K131304 |
510k Number | K131304 |
Device Name: | SENTIO MMG |
Classification | Neurosurgical Nerve Locator |
Applicant | INNOVATIVE SURGICAL SOLUTIONS, LLC ("ISS") 21520 BRIDGE STREET Southfield, MI 48033 |
Contact | Aashish Shah |
Correspondent | Aashish Shah INNOVATIVE SURGICAL SOLUTIONS, LLC ("ISS") 21520 BRIDGE STREET Southfield, MI 48033 |
Product Code | PDQ |
CFR Regulation Number | 874.1820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-05-07 |
Decision Date | 2014-05-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00853926005068 | K131304 | 000 |
00853926005051 | K131304 | 000 |
00853926005044 | K131304 | 000 |
00853926005037 | K131304 | 000 |
00853926005020 | K131304 | 000 |
00853926005013 | K131304 | 000 |
00853926005006 | K131304 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SENTIO MMG 85337435 4180638 Live/Registered |
Innovative Surgical Solutions, LLC 2011-06-03 |