The following data is part of a premarket notification filed by Activatek Inc. with the FDA for Activapatch Et Iontophoresis Patch.
Device ID | K132832 |
510k Number | K132832 |
Device Name: | ACTIVAPATCH ET IONTOPHORESIS PATCH |
Classification | Device, Iontophoresis, Other Uses |
Applicant | ACTIVATEK INC. 2734 S. 3600 WEST UNIT F West Valley City, UT 84119 |
Contact | Jamal Yanaki |
Correspondent | Jamal Yanaki ACTIVATEK INC. 2734 S. 3600 WEST UNIT F West Valley City, UT 84119 |
Product Code | EGJ |
CFR Regulation Number | 890.5525 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-09-10 |
Decision Date | 2014-02-13 |
Summary: | summary |