The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Urethral Suture Guide.
| Device ID | K950267 |
| 510k Number | K950267 |
| Device Name: | URETHRAL SUTURE GUIDE |
| Classification | Surgical Instruments, G-u, Manual (and Accessories) |
| Applicant | APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Contact | Mary Jo S Tegwell |
| Correspondent | Mary Jo S Tegwell APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Product Code | KOA |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-23 |
| Decision Date | 1995-01-31 |