The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Neuromusclar Ii.
| Device ID | K840346 |
| 510k Number | K840346 |
| Device Name: | NEUROMUSCLAR II |
| Classification | Stimulator, Muscle, Powered |
| Applicant | MENTOR CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-26 |
| Decision Date | 1984-02-10 |