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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resectoscope, Working Element
510(k) Number K895643
Device Name MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM
Applicant
Orthoconcept, Inc.
8 Cold Branch Ct.
Columbia,  SC  29223
Applicant Contact JACK DEFRANCO
Correspondent
Orthoconcept, Inc.
8 Cold Branch Ct.
Columbia,  SC  29223
Correspondent Contact JACK DEFRANCO
Regulation Number876.1500
Classification Product Code
FDC  
Date Received08/28/1989
Decision Date 10/17/1989
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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