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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K040634
Device Name ROBERTSITE VIAL ADAPTER, MODEL 245700021
Applicant
HALKEY-ROBERTS CORP.
11600 M.L. KING BLVD.,NORTH
ST. PETERSBURG,  FL  33716
Applicant Contact JOHN SHELDON
Correspondent
UNDERWRITERS LABORATORIES, INC.
12 LABORATORY DR.
RESEARCH TRIANGLE,  NC  27709
Correspondent Contact SUSAN GILL
Regulation Number880.5440
Classification Product Code
LHI  
Date Received03/10/2004
Decision Date 03/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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