The following data is part of a premarket notification filed by Selective Med Components, Inc. with the FDA for Medion 6000.
Device ID | K020476 |
510k Number | K020476 |
Device Name: | MEDION 6000 |
Classification | Device, Iontophoresis, Other Uses |
Applicant | SELECTIVE MED COMPONENTS, INC. 6 MECHANIC ST. Mount Vernon, OH 43050 |
Contact | Richard Fisher |
Correspondent | Richard Fisher SELECTIVE MED COMPONENTS, INC. 6 MECHANIC ST. Mount Vernon, OH 43050 |
Product Code | EGJ |
CFR Regulation Number | 890.5525 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-02-12 |
Decision Date | 2002-05-03 |
Summary: | summary |