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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K990777
Device Name MED-RX EXTENSION SETS
Applicant
Benlan, Inc.
2760 Brighton Rd.
Oakville,  CA L6H 5T4
Applicant Contact BILL C.K. LIM
Correspondent
Benlan, Inc.
2760 Brighton Rd.
Oakville,  CA L6H 5T4
Correspondent Contact BILL C.K. LIM
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/09/1999
Decision Date 08/25/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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