510(k) K103812
K103812 is an FDA 510(k) premarket notification submitted by Sciencity Co., Ltd. for the device "MITRA-LIFT". The FDA issued a decision of Substantially Equivalent on May 18, 2011. The device falls under product code KRH (Ring, Annuloplasty), a Class II device regulated under 21 CFR 870.3800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 18, 2011
- Date Received
- December 29, 2010
- 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