510(k) K001712
K001712 is an FDA 510(k) premarket notification submitted by The Saunders Group for the device "3D ACTIVETRAC". The FDA issued a decision of Substantially Equivalent on August 31, 2000. The device falls under product code ITH (Equipment, Traction, Powered), a Class II device regulated under 21 CFR 890.5900. The Saunders Group has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 2000
- Date Received
- June 5, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Equipment, Traction, Powered
- Device Class
- Class II
- Regulation Number
- 890.5900
- Review Panel
- PM
- Submission Type