The following data is part of a premarket notification filed by Vioptix, Inc. with the FDA for Vesselink Microvascular Anastomotic Coupler System.
| Device ID | K090679 |
| 510k Number | K090679 |
| Device Name: | VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM |
| Classification | Device, Anastomotic, Microvascular |
| Applicant | VIOPTIX, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Grace Holland |
| Correspondent | Grace Holland VIOPTIX, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | MVR |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-16 |
| Decision Date | 2009-04-17 |
| Summary: | summary |