The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Atraumax Surgical Clamp.
| Device ID | K950492 |
| 510k Number | K950492 |
| Device Name: | ATRAUMAX SURGICAL CLAMP |
| Classification | Clamp, Vascular |
| Applicant | APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Contact | Howard V Rowe |
| Correspondent | Howard V Rowe APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-06 |
| Decision Date | 1995-05-08 |