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 |