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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, gynecologic (and accessories)
510(k) Number K980166
Device Name LIGHTSOURCE OR ILLUMINATOR
Applicant
CUDA PRODUCTS CO.
6000 POWERS AVE.
JACKSONVILLE,  FL  32217
Applicant Contact KIM REEK
Correspondent
CUDA PRODUCTS CO.
6000 POWERS AVE.
JACKSONVILLE,  FL  32217
Correspondent Contact KIM REEK
Regulation Number884.1720
Classification Product Code
HET  
Subsequent Product Codes
FCR   FCW   FFS   HBI  
Date Received01/16/1998
Decision Date 04/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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