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FDA 510(k) Application Details - K133322
Device Classification Name
Indicator, Biological Sterilization Process
More FDA Info for this Device
510(K) Number
K133322
Device Name
Indicator, Biological Sterilization Process
Applicant
STERITEC PRODUCTS MFG., CO., INC.
74 INVERNESS DRIVE EAST
ENGLEWOOD, CO 80112 US
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Contact
JONATHAN RUTIGLIANO
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
10/29/2013
Decision Date
08/25/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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