510(k) K040163
K040163 is an FDA 510(k) premarket notification submitted by Synovis Micro Companies Alliance, Inc. for the device "MICROVASCULAR ANASTOMOTIC DEVICE". The FDA issued a decision of Substantially Equivalent on April 16, 2004. The device falls under product code MVR (Device, Anastomotic, Microvascular), a Class II device regulated under 21 CFR 878.4300. Synovis Micro Companies Alliance, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 16, 2004
- Date Received
- January 26, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Anastomotic, Microvascular
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type