510(k) K073132
K073132 is an FDA 510(k) premarket notification submitted by North American Medical Corp (Nam) for the device "MODEL D DISC FORCE". The FDA issued a decision of Substantially Equivalent on April 3, 2008. The device falls under product code ITH (Equipment, Traction, Powered), a Class II device regulated under 21 CFR 890.5900. North American Medical Corp (Nam) has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 3, 2008
- Date Received
- November 7, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Equipment, Traction, Powered
- Device Class
- Class II
- Regulation Number
- 890.5900
- Review Panel
- PM
- Submission Type