510(k) K113600
K113600 is an FDA 510(k) premarket notification submitted by Synexmed(Shenzhen)Company Limited for the device "IM BAND". The FDA issued a decision of Substantially Equivalent on February 8, 2012. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Synexmed(Shenzhen)Company Limited has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 2012
- Date Received
- December 5, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Vascular
- Device Class
- Class II
- Regulation Number
- 870.4450
- Review Panel
- CV
- Submission Type