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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Irrigation, Urological
510(k) Number K010607
Device Name MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001
Applicant
BENLAN, INC.
2760 BRIGHTON RD.
OAKVILLE, ONTARIO,  CA L6H 5T4
Applicant Contact BILL LIM
Correspondent
BENLAN, INC.
2760 BRIGHTON RD.
OAKVILLE, ONTARIO,  CA L6H 5T4
Correspondent Contact BILL LIM
Regulation Number876.5130
Classification Product Code
LJH  
Date Received03/01/2001
Decision Date 11/28/2001
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
Recalls CDRH Recalls
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