The following data is part of a premarket notification filed by Candela Laser Corp. with the FDA for Lasertripter Miniscope.
Device ID | K874858 |
510k Number | K874858 |
Device Name: | LASERTRIPTER MINISCOPE |
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 | 1987-11-25 |
Decision Date | 1988-02-19 |