The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor 150 Plus Transcutaneous Elec..
Device ID | K842812 |
510k Number | K842812 |
Device Name: | MENTOR 150 PLUS TRANSCUTANEOUS ELEC. |
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 | 1984-07-18 |
Decision Date | 1984-08-08 |