The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Stimulator, Mentor 100 Nerve.
Device ID | K790011 |
510k Number | K790011 |
Device Name: | STIMULATOR, MENTOR 100 NERVE |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | MENTOR CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-02 |
Decision Date | 1979-03-02 |