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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope Channel Accessory
510(k) Number K920030
Device Name SURESEAL ENDOSCOPIC VALVE
Applicant
Applied Urology, Inc.
26051 Merit Cir.
Bldg. 104
Launa Hills,  CA  92653
Applicant Contact JO STEGWELL
Correspondent
Applied Urology, Inc.
26051 Merit Cir.
Bldg. 104
Launa Hills,  CA  92653
Correspondent Contact JO STEGWELL
Regulation Number876.1500
Classification Product Code
ODC  
Date Received01/03/1992
Decision Date 03/18/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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