The following data is part of a premarket notification filed by Mcg, Inc. with the FDA for Electroapplicator Model C-1.
Device ID | K790205 |
510k Number | K790205 |
Device Name: | ELECTROAPPLICATOR MODEL C-1 |
Classification | Device, Iontophoresis, Specific Uses |
Applicant | MCG, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KTB |
CFR Regulation Number | 890.5525 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-31 |
Decision Date | 1979-03-19 |