The following data is part of a premarket notification filed by Med General with the FDA for Ceptortrode With Ceptor Hesive.
Device ID | K791097 |
510k Number | K791097 |
Device Name: | CEPTORTRODE WITH CEPTOR HESIVE |
Classification | Electrode, Cutaneous |
Applicant | MED GENERAL 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-06-12 |
Decision Date | 1979-08-03 |