The following data is part of a premarket notification filed by Intramed Laboratories, Inc. with the FDA for Flexible Choledochoscope.
| Device ID | K901010 |
| 510k Number | K901010 |
| Device Name: | FLEXIBLE CHOLEDOCHOSCOPE |
| Classification | Choledochoscope And Accessories, Flexible/rigid |
| Applicant | INTRAMED LABORATORIES, INC. 11100 ROSELLE ST. San Diego, CA 92121 |
| Contact | Stephen Sosnowski |
| Correspondent | Stephen Sosnowski INTRAMED LABORATORIES, INC. 11100 ROSELLE ST. San Diego, CA 92121 |
| Product Code | FBN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-05 |
| Decision Date | 1990-05-22 |