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 |