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 |