The following data is part of a premarket notification filed by North Coast Medical, Inc. with the FDA for North Coast Buffered Iontophoresis Electrode.
| Device ID | K052019 |
| 510k Number | K052019 |
| Device Name: | NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | NORTH COAST MEDICAL, INC. 18305 SUTTER BLVD. Morgan Hill, CA 95037 -2845 |
| Contact | Tarhan Kayihan |
| Correspondent | Tarhan Kayihan NORTH COAST MEDICAL, INC. 18305 SUTTER BLVD. Morgan Hill, CA 95037 -2845 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-07-26 |
| Decision Date | 2005-11-04 |
| Summary: | summary |