510(k) K112606
K112606 is an FDA 510(k) premarket notification submitted by Activator Methods International, Ltd. for the device "ACTIVATOR V-E". The FDA issued a decision of Substantially Equivalent on March 6, 2012. The device falls under product code LXM (Manipulator, Plunger-Like Joint), a Class U device. Activator Methods International, Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 6, 2012
- Date Received
- September 8, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Manipulator, Plunger-Like Joint
- Device Class
- Class U
- Regulation Number
- Review Panel
- PM
- Submission Type