The following data is part of a premarket notification filed by Maxxim Medical with the FDA for Dynaphor(tm) Two.
| Device ID | K935868 |
| 510k Number | K935868 |
| Device Name: | DYNAPHOR(TM) TWO |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | MAXXIM MEDICAL 104 INDUSTRIAL BLVD. Sugar Land, TX 77478 |
| Contact | Ernest J Henley |
| Correspondent | Ernest J Henley MAXXIM MEDICAL 104 INDUSTRIAL BLVD. Sugar Land, TX 77478 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-06 |
| Decision Date | 1995-03-15 |
| Summary: | summary |