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 |