510(k) K132675
K132675 is an FDA 510(k) premarket notification submitted by Celonova Biosciences, Inc. for the device "EMBOZENE MICROSPHERES". The FDA issued a decision of Substantially Equivalent on October 3, 2013. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Celonova Biosciences, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 2013
- Date Received
- August 28, 2013
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Vascular, For Promoting Embolization
- Device Class
- Class II
- Regulation Number
- 870.3300
- Review Panel
- CV
- Submission Type