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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 K861687
Device Name BIOJECTOR SYRINGE SYSTEM
Applicant
Bioject, Inc.
630 Parkside Center, 2020 SW
Fouth Ave.
Portland,  OR  97201
Applicant Contact ALFRED ARONSON
Correspondent
Bioject, Inc.
630 Parkside Center, 2020 SW
Fouth Ave.
Portland,  OR  97201
Correspondent Contact ALFRED ARONSON
Regulation Number880.5430
Classification Product Code
KZE  
Date Received05/02/1986
Decision Date 04/23/1987
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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