The following data is part of a premarket notification filed by Cuda Products Co. with the FDA for Laser Laparoscopy Set.
Device ID | K873598 |
510k Number | K873598 |
Device Name: | LASER LAPAROSCOPY SET |
Classification | Laparoscope, Gynecologic (and Accessories) |
Applicant | CUDA PRODUCTS CO. 6000 POWERS AVE. Jacksonville, FL 32217 |
Contact | Larry Cohen |
Correspondent | Larry Cohen CUDA PRODUCTS CO. 6000 POWERS AVE. Jacksonville, FL 32217 |
Product Code | HET |
CFR Regulation Number | 884.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-04 |
Decision Date | 1988-01-20 |