LASER LAPAROSCOPY SET

Laparoscope, Gynecologic (and Accessories)

CUDA PRODUCTS CO.

The following data is part of a premarket notification filed by Cuda Products Co. with the FDA for Laser Laparoscopy Set.

Pre-market Notification Details

Device IDK873598
510k NumberK873598
Device Name:LASER LAPAROSCOPY SET
ClassificationLaparoscope, Gynecologic (and Accessories)
Applicant CUDA PRODUCTS CO. 6000 POWERS AVE. Jacksonville,  FL  32217
ContactLarry Cohen
CorrespondentLarry Cohen
CUDA PRODUCTS CO. 6000 POWERS AVE. Jacksonville,  FL  32217
Product CodeHET  
CFR Regulation Number884.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-04
Decision Date1988-01-20

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