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FDA 510(k) Application Details - K041179
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K041179
Device Name
Set, Administration, Intravascular
Applicant
MEDEGEN MEDICAL MANUFACTURING SERVICES, INC.
930 WANAMAKER
ONTARIO, CA 91761-8151 US
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Contact
TIM TRUITT
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/06/2004
Decision Date
06/04/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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