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FDA 510(k) Application Details - K050591
Device Classification Name
Indicator, Biological Sterilization Process
More FDA Info for this Device
510(K) Number
K050591
Device Name
Indicator, Biological Sterilization Process
Applicant
RAVEN BIOLOGICAL LABORATORIES, INC.
8607 PARK DR.
OMAHA, NE 68127 US
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Contact
WENDY ROYALTY-HANN
Other 510(k) Applications for this Contact
Regulation Number
880.2800
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Classification Product Code
FRC
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More FDA Info for this Product Code
Date Received
03/08/2005
Decision Date
03/23/2005
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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