The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Activator Neuromuscular Stimu.
Device ID | K820168 |
510k Number | K820168 |
Device Name: | MENTOR ACTIVATOR NEUROMUSCULAR STIMU |
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 | 1982-01-21 |
Decision Date | 1982-02-24 |