The following data is part of a premarket notification filed by Candela Laser Corp. with the FDA for Candela Mini-ub Endoscope.
Device ID | K910732 |
510k Number | K910732 |
Device Name: | CANDELA MINI-UB ENDOSCOPE |
Classification | Mini Endoscope, Gastroenterology-urology |
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 | ODF |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-02-21 |
Decision Date | 1991-04-12 |