510(k) K882967
K882967 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "BONE FIXATION WIRE". The FDA issued a decision of Substantially Equivalent on Sep 30, 1988. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 30, 1988
- Date Received
- Jul 15, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Cerclage, Fixation
- Device Class
- Class II
- Regulation Number
- 888.3010
- Review Panel
- OR
- Submission Type
- 510(k)