510(k) K090428
K090428 is an FDA 510(k) premarket notification submitted by Genesee Biomedical, Inc. for the device "ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC". The FDA issued a decision of Substantially Equivalent on May 7, 2009. 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
- May 7, 2009
- Date Received
- February 19, 2009
- Clearance Type
- Special
- 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