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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 K090003
Device Name ZETAJET
Applicant
BIOJECT, INC.
20245 S.W. 95TH AVE.
TUALATIN,  OR  97062
Applicant Contact KRIS RICHARD
Correspondent
BIOJECT, INC.
20245 S.W. 95TH AVE.
TUALATIN,  OR  97062
Correspondent Contact KRIS RICHARD
Regulation Number880.5430
Classification Product Code
KZE  
Date Received01/02/2009
Decision Date 04/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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