The following data is part of a premarket notification filed by Pepin Mfg., Inc. with the FDA for Comfort/io Iontophoresis Electrodes.
| Device ID | K060579 |
| 510k Number | K060579 |
| Device Name: | COMFORT/IO IONTOPHORESIS ELECTRODES |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | PEPIN MFG., INC. 800 LEVANGER LANE Stoughton, WI 53589 |
| Contact | Gary Syring |
| Correspondent | Gary Syring PEPIN MFG., INC. 800 LEVANGER LANE Stoughton, WI 53589 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-06 |
| Decision Date | 2006-04-20 |
| Summary: | summary |