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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscope, fiber optic
510(k) Number K935818
Device Name ENDOSCOPE
Applicant
CUDA PRODUCTS CO.
6000 POWERS AVE.
JACKSONVILLE,  FL  32217
Applicant Contact JOSEPH CUDA
Correspondent
CUDA PRODUCTS CO.
6000 POWERS AVE.
JACKSONVILLE,  FL  32217
Correspondent Contact JOSEPH CUDA
Regulation Number876.1500
Classification Product Code
GDB  
Date Received12/02/1993
Decision Date 07/13/1994
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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