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FDA 510(k) Application Details - K020205
Device Classification Name
Indicator, Biological Sterilization Process
More FDA Info for this Device
510(K) Number
K020205
Device Name
Indicator, Biological Sterilization Process
Applicant
GETINGE/CASTLE, INC.
1777 EAST HENRIETTA RD.
ROCHESTER, NY 14623-3133 US
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Contact
MARK N SMITH
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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
01/22/2002
Decision Date
06/24/2002
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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