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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 K920631
Device Name BIOJECT JET INJECTION SYSTEM
Applicant
Bioject, Inc.
7620 SW Bridgeport Rd.
Portland,  OR  97224
Applicant Contact STEVEN F PETERSON
Correspondent
Bioject, Inc.
7620 SW Bridgeport Rd.
Portland,  OR  97224
Correspondent Contact STEVEN F PETERSON
Regulation Number880.5430
Classification Product Code
KZE  
Date Received02/12/1992
Decision Date 06/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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