The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Cholangiography Catheter.
| Device ID | K924128 |
| 510k Number | K924128 |
| Device Name: | CHOLANGIOGRAPHY CATHETER |
| Classification | Catheter, Cholangiography |
| Applicant | APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Contact | Jo Stegwell |
| Correspondent | Jo Stegwell APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Product Code | GBZ |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-17 |
| Decision Date | 1993-02-10 |