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FDA 510(k) Application Details - K050734
Device Classification Name
Injector, Fluid, Non-Electrically Powered
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510(K) Number
K050734
Device Name
Injector, Fluid, Non-Electrically Powered
Applicant
BIOJECT, INC.
20245 S.W. 95TH AVE.
TUALATIN, OR 97062 US
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Contact
MELANIE TALBERT
Other 510(k) Applications for this Contact
Regulation Number
880.5430
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Classification Product Code
KZE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/21/2005
Decision Date
06/03/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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