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FDA 510(k) Application Details - K960777
Device Classification Name
Indicator, Biological Sterilization Process
More FDA Info for this Device
510(K) Number
K960777
Device Name
Indicator, Biological Sterilization Process
Applicant
MDT CORP., INC.
P.O BOX 23077
ROCHESTER, NY 14692 US
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Contact
CHARLES O HANCOCK
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
02/26/1996
Decision Date
05/23/1996
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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