The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for External Vein Stripper.
| Device ID | K933498 |
| 510k Number | K933498 |
| Device Name: | EXTERNAL VEIN STRIPPER |
| Classification | Stripper, Artery, Intraluminal |
| Applicant | APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Contact | Mary Jo Stegwell |
| Correspondent | Mary Jo Stegwell APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Product Code | DWX |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-19 |
| Decision Date | 1994-03-23 |