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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Fluid, Non-Electrically Powered
510(k) Number K960373
Device Name BIOJECTOR 2000 MODEL 1B02000
Applicant
Bioject, Inc.
7620 SW Bridgeport Rd.
Portland,  OR  97224
Applicant Contact MARK K NORTON
Correspondent
Bioject, Inc.
7620 SW Bridgeport Rd.
Portland,  OR  97224
Correspondent Contact MARK K NORTON
Regulation Number880.5430
Classification Product Code
KZE  
Date Received01/26/1996
Decision Date 03/05/1997
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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