The following data is part of a premarket notification filed by Applied Vascular Devices, Inc. with the FDA for Atraumax Surgical Clamp Model Fog-5048, 75mm Side.
| Device ID | K901565 |
| 510k Number | K901565 |
| Device Name: | ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDE |
| Classification | Clamp, Vascular |
| Applicant | APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #104 Laguna Hills, CA 92653 |
| Contact | Robert P Cooper |
| Correspondent | Robert P Cooper APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #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 | 1990-04-03 |
| Decision Date | 1990-06-12 |