510(k) K072432
K072432 is an FDA 510(k) premarket notification submitted by Hand Biomechanics Lab, Inc. for the device "F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE". The FDA issued a decision of Substantially Equivalent on January 9, 2008. The device falls under product code JEC (Component, Traction, Invasive), a Class II device regulated under 21 CFR 888.3040. Hand Biomechanics Lab, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 2008
- Date Received
- August 29, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Component, Traction, Invasive
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type