The following data is part of a premarket notification filed by Vascutech, Inc. with the FDA for Lemaitre-bookwalter Vessel Devices.
Device ID | K912548 |
510k Number | K912548 |
Device Name: | LEMAITRE-BOOKWALTER VESSEL DEVICES |
Classification | Dilator, Vessel, Surgical |
Applicant | VASCUTECH, INC. 140 HAVERHILL ST. Andover, MA 01810 |
Contact | Lisa A Pare |
Correspondent | Lisa A Pare VASCUTECH, INC. 140 HAVERHILL ST. Andover, MA 01810 |
Product Code | DWP |
CFR Regulation Number | 870.4475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-06-10 |
Decision Date | 1991-09-18 |