The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Applied Medical Optical Valvulotome.
| Device ID | K945591 |
| 510k Number | K945591 |
| Device Name: | APPLIED MEDICAL OPTICAL VALVULOTOME |
| Classification | Angioscope |
| Applicant | APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Contact | Mary J Stegwell |
| Correspondent | Mary J Stegwell APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Product Code | LYK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-14 |
| Decision Date | 1995-02-10 |