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 |