510(k) K191513
K191513 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "Altapore Shape". The FDA issued a decision of Substantially Equivalent on Oct 19, 2019. 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
- Oct 19, 2019
- Date Received
- Jun 7, 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)