510(k) K181585
K181585 is an FDA 510(k) premarket notification submitted by AgNovos Healthcare USA, LLC for the device "JGH1 Core Deccompression Procedure Kit". The FDA issued a decision of Substantially Equivalent on Jul 20, 2018. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. AgNovos Healthcare USA, LLC has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 20, 2018
- Date Received
- Jun 15, 2018
- 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)