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 |