The following data is part of a premarket notification filed by Henley Intl. with the FDA for Jeltrode.
Device ID | K861956 |
510k Number | K861956 |
Device Name: | JELTRODE |
Classification | Electrode, Cutaneous |
Applicant | HENLEY INTL. 10518 KINGHURST Houston, TX 77099 |
Contact | Ernest J Henley |
Correspondent | Ernest J Henley HENLEY INTL. 10518 KINGHURST Houston, TX 77099 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-05-20 |
Decision Date | 1986-06-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
JELTRODE 73609685 1486033 Dead/Cancelled |
NEUROMEDICS, INC. 1986-07-14 |