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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Choledochoscope And Accessories, Flexible/Rigid
510(k) Number K924228
Device Name OMEGASCOPE
Applicant
OMEGA UNIVERSAL TECHNOLOGIES, LTD.
28 MARIGOLD LN.
MARLBORO,  NJ  07746
Applicant Contact MARTIN S KNOPF
Correspondent
OMEGA UNIVERSAL TECHNOLOGIES, LTD.
28 MARIGOLD LN.
MARLBORO,  NJ  07746
Correspondent Contact MARTIN S KNOPF
Regulation Number876.1500
Classification Product Code
FBN  
Date Received08/21/1992
Decision Date 02/26/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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