The following data is part of a premarket notification filed by Henley Intl. with the FDA for Chempad(tm), Electroconductive Media (882.1275).
Device ID | K901630 |
510k Number | K901630 |
Device Name: | CHEMPAD(TM), ELECTROCONDUCTIVE MEDIA (882.1275) |
Classification | Media, Electroconductive |
Applicant | HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
Contact | Henley, Phd |
Correspondent | Henley, Phd 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 | 1990-04-09 |
Decision Date | 1990-07-16 |