510(k) K161815
K161815 is an FDA 510(k) premarket notification submitted by Genesee Biomedical, Inc. for the device "FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band". The FDA issued a decision of Substantially Equivalent on October 12, 2016. The device falls under product code KRH (Ring, Annuloplasty), a Class II device regulated under 21 CFR 870.3800. Genesee Biomedical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 12, 2016
- Date Received
- July 1, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ring, Annuloplasty
- Device Class
- Class II
- Regulation Number
- 870.3800
- Review Panel
- CV
- Submission Type