The following data is part of a premarket notification filed by Candela Laser Corp. with the FDA for Candela Directable Biliary Catheter System.
| Device ID | K900904 |
| 510k Number | K900904 |
| Device Name: | CANDELA DIRECTABLE BILIARY CATHETER SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | CANDELA LASER CORP. 530 BOSTON POST RD. Wayland, MA 01778 |
| Contact | George Cho |
| Correspondent | George Cho CANDELA LASER CORP. 530 BOSTON POST RD. Wayland, MA 01778 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-27 |
| Decision Date | 1990-05-11 |