The following data is part of a premarket notification filed by Selective Med Components, Inc. with the FDA for Io-drive.
Device ID | K993081 |
510k Number | K993081 |
Device Name: | IO-DRIVE |
Classification | Device, Iontophoresis, Other Uses |
Applicant | SELECTIVE MED COMPONENTS, INC. 6 S. MECHANIC ST. Mount Vernon, OH 43050 |
Contact | Rick Fisher |
Correspondent | Rick Fisher SELECTIVE MED COMPONENTS, INC. 6 S. 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 | 1999-09-15 |
Decision Date | 2000-03-03 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
IO-DRIVE 75865474 not registered Dead/Abandoned |
Selective Med Components 1999-12-20 |