510(k) K192363
K192363 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "Altapore". The FDA issued a decision of Substantially Equivalent on Jan 9, 2020. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Baxter Healthcare Corporation has 60 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 9, 2020
- Date Received
- Aug 30, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filler, Bone Void, Calcium Compound
- Device Class
- Class II
- Regulation Number
- 888.3045
- Review Panel
- OR
- Submission Type
- 510(k)