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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 K963012
Device Name BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM)
Applicant
Bioject, Inc.
7620 SW Bridgeport Rd.
Portland,  OR  97224
Applicant Contact JEFF SNOW
Correspondent
Bioject, Inc.
7620 SW Bridgeport Rd.
Portland,  OR  97224
Correspondent Contact JEFF SNOW
Regulation Number880.5440
Classification Product Code
LHI  
Date Received08/02/1996
Decision Date 10/15/1996
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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