The following data is part of a premarket notification filed by Activator Methods International Ltd. with the FDA for Activator V-e.
Device ID | K112606 |
510k Number | K112606 |
Device Name: | ACTIVATOR V-E |
Classification | Manipulator, Plunger-like Joint |
Applicant | ACTIVATOR METHODS INTERNATIONAL LTD. 2950 N. SEVENTH ST. Phoenix, AZ 85014 |
Contact | Arlan W Fuhr |
Correspondent | Arlan W Fuhr ACTIVATOR METHODS INTERNATIONAL LTD. 2950 N. SEVENTH ST. Phoenix, AZ 85014 |
Product Code | LXM |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-09-08 |
Decision Date | 2012-03-06 |