The following data is part of a premarket notification filed by Selective Med Components, Inc. with the FDA for Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes, Models I20, I30, I40, I50, And I7.
Device ID | K031053 |
510k Number | K031053 |
Device Name: | SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7 |
Classification | Device, Iontophoresis, Other Uses |
Applicant | SELECTIVE MED COMPONENTS, INC. 201 WEST HIGH ST. Mount Vernon, OH 43050 |
Contact | Richard J Fisher |
Correspondent | Richard J Fisher SELECTIVE MED COMPONENTS, INC. 201 WEST HIGH 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 | Yes |
Date Received | 2003-04-02 |
Decision Date | 2003-05-20 |
Summary: | summary |