The following data is part of a premarket notification filed by Candela Laser Corp. with the FDA for Mini-ub Endoscopes.
| Device ID | K941230 |
| 510k Number | K941230 |
| Device Name: | MINI-UB ENDOSCOPES |
| Classification | Mini Endoscope, Gastroenterology-urology |
| Applicant | CANDELA LASER CORP. 530 BOSTON POST RD. Wayland, MA 01778 |
| Contact | Joseph Lowery |
| Correspondent | Joseph Lowery CANDELA LASER CORP. 530 BOSTON POST RD. Wayland, MA 01778 |
| Product Code | ODF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-15 |
| Decision Date | 1994-06-17 |