The following data is part of a premarket notification filed by Lemaitre Vascular, Inc. with the FDA for Lemaitre Vascular Disposable Vein Stripper.
| Device ID | K023688 |
| 510k Number | K023688 |
| Device Name: | LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER |
| Classification | Spatula, Surgical, General & Plastic Surgery |
| Applicant | LEMAITRE VASCULAR, INC. 26 RAY AVE. Burlington, MA 01803 |
| Contact | James Ashby |
| Correspondent | James Ashby LEMAITRE VASCULAR, INC. 26 RAY AVE. Burlington, MA 01803 |
| Product Code | GAF |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-01 |
| Decision Date | 2003-01-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840663100415 | K023688 | 000 |