The following data is part of a premarket notification filed by Henley Intl. with the FDA for Dynaphor(tm) 101, Iontophoresis Device.
Device ID | K894549 |
510k Number | K894549 |
Device Name: | DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE |
Classification | Device, Iontophoresis, Other Uses |
Applicant | HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
Contact | Ernest J Henley,phd |
Correspondent | Ernest J Henley,phd HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
Product Code | EGJ |
CFR Regulation Number | 890.5525 [🔎] |
Decision | Substantially Equivalent - With Drug (SESD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-07-20 |
Decision Date | 1990-02-09 |