The following data is part of a premarket notification filed by Empi with the FDA for Iontophoresis Device.
Device ID | K903093 |
510k Number | K903093 |
Device Name: | IONTOPHORESIS DEVICE |
Classification | Device, Iontophoresis, Other Uses |
Applicant | EMPI 1275 GREY FOX RD. St Paul, MN 55112 |
Contact | Stacy Mattson |
Correspondent | Stacy Mattson EMPI 1275 GREY FOX RD. St Paul, MN 55112 |
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 | 1990-07-13 |
Decision Date | 1990-10-11 |