The following data is part of a premarket notification filed by Synovis Micro Companies Alliance, Inc. with the FDA for Microvascular Anastomotic Device.
| Device ID | K040163 |
| 510k Number | K040163 |
| Device Name: | MICROVASCULAR ANASTOMOTIC DEVICE |
| Classification | Device, Anastomotic, Microvascular |
| Applicant | SYNOVIS MICRO COMPANIES ALLIANCE, INC. 439 INDUSTRIAL LN. Birmingham, AL 35211 -4464 |
| Contact | Daisy P Sin |
| Correspondent | Daisy P Sin SYNOVIS MICRO COMPANIES ALLIANCE, INC. 439 INDUSTRIAL LN. Birmingham, AL 35211 -4464 |
| Product Code | MVR |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-26 |
| Decision Date | 2004-04-16 |
| Summary: | summary |