510(k) K052899
K052899 is an FDA 510(k) premarket notification submitted by Genesee Biomedical, Inc. for the device "ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC". The FDA issued a decision of Substantially Equivalent on November 17, 2005. 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
- November 17, 2005
- Date Received
- October 14, 2005
- 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