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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Adaptor, Bulbs, Miscellaneous, For Endoscope
510(k) Number K900781
Device Name WORKING CHANNEL VALVE
Applicant
APPLIED UROLOGY, INC.
26051 MERIT CIRCLE, BLDG. 104
LAGUNA HILLS,  CA  92653
Applicant Contact NABIL HILAL
Correspondent
APPLIED UROLOGY, INC.
26051 MERIT CIRCLE, BLDG. 104
LAGUNA HILLS,  CA  92653
Correspondent Contact NABIL HILAL
Regulation Number876.1500
Classification Product Code
FFY  
Date Received02/20/1990
Decision Date 04/25/1990
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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