510(k) K940666
K940666 is an FDA 510(k) premarket notification submitted by J.B.S., S.A. for the device "JBS SMOOTH FIXATION PIN". The FDA issued a decision of Substantially Equivalent on Nov 14, 1994. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. J.B.S., S.A. has 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 14, 1994
- Date Received
- Feb 16, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pin, Fixation, Smooth
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
- 510(k)