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FDA 510(k) Application Details - K072408
Device Classification Name
Indicator, Physical/Chemical Sterilization Process
More FDA Info for this Device
510(K) Number
K072408
Device Name
Indicator, Physical/Chemical Sterilization Process
Applicant
STERITEC PRODUCTS MFG. CO., INC.
599 TOPEKA WAY
SUITE 400
CASTLE ROCK, CO 80109 US
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Contact
LINDA NELSON
Other 510(k) Applications for this Contact
Regulation Number
880.2800
More FDA Info for this Regulation Number
Classification Product Code
JOJ
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More FDA Info for this Product Code
Date Received
08/27/2007
Decision Date
04/30/2008
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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