The following data is part of a premarket notification filed by Iomed, Inc. with the FDA for Mw-1000 Iontophoretic Drug Delivery Electrode.
Device ID | K060236 |
510k Number | K060236 |
Device Name: | MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE |
Classification | Device, Iontophoresis, Other Uses |
Applicant | IOMED, INC. 2441 SOUTH 3850 WEST, SUITE A Salt Lake City, UT 84120 -9941 |
Contact | Curtis Jensen |
Correspondent | Curtis Jensen IOMED, INC. 2441 SOUTH 3850 WEST, SUITE A Salt Lake City, UT 84120 -9941 |
Product Code | EGJ |
CFR Regulation Number | 890.5525 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-01-30 |
Decision Date | 2006-03-31 |
Summary: | summary |