The following data is part of a premarket notification filed by Henley Intl. with the FDA for Electroconductive Media.
Device ID | K904377 |
510k Number | K904377 |
Device Name: | ELECTROCONDUCTIVE MEDIA |
Classification | Media, Electroconductive |
Applicant | HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
Contact | Ernest Henley |
Correspondent | Ernest Henley HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
Product Code | GYB |
CFR Regulation Number | 882.1275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-09-24 |
Decision Date | 1991-11-15 |