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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 K873598
Device Name LASER LAPAROSCOPY SET
Applicant
Cuda Products Co.
6000 Powers Ave.
Jacksonville,  FL  32217
Applicant Contact LARRY COHEN
Correspondent
Cuda Products Co.
6000 Powers Ave.
Jacksonville,  FL  32217
Correspondent Contact LARRY COHEN
Regulation Number884.1720
Classification Product Code
HET  
Date Received09/04/1987
Decision Date 01/20/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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