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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 K994384
Device Name CLICKER
Applicant
BIOJECT, INC.
7620 S.W. BRIDGEPORT RD.
PORTLAND,  OR  97224
Applicant Contact NANCY GERTLAR
Correspondent
BIOJECT, INC.
7620 S.W. BRIDGEPORT RD.
PORTLAND,  OR  97224
Correspondent Contact NANCY GERTLAR
Regulation Number880.5430
Classification Product Code
KZE  
Date Received12/28/1999
Decision Date 06/22/2000
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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