The following data is part of a premarket notification filed by Candela Laser Corp. with the FDA for Candela Miniflex Deflectable Ureteroscope.
| Device ID | K884153 |
| 510k Number | K884153 |
| Device Name: | CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| 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 | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-30 |
| Decision Date | 1988-12-28 |