The following data is part of a premarket notification filed by Activatek Inc. with the FDA for Activapatch.
Device ID | K091326 |
510k Number | K091326 |
Device Name: | ACTIVAPATCH |
Classification | Device, Iontophoresis, Other Uses |
Applicant | ACTIVATEK INC. 2734 S. 3600 WEST UNIT F West Valley, UT 84120 |
Contact | Jamal Yanaki |
Correspondent | Jamal Yanaki ACTIVATEK INC. 2734 S. 3600 WEST UNIT F West Valley, UT 84120 |
Product Code | EGJ |
CFR Regulation Number | 890.5525 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-05-05 |
Decision Date | 2009-05-27 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ACTIVAPATCH 77151962 3763642 Live/Registered |
ActivaTek, Inc. 2007-04-09 |