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 |