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FDA 510(k) Application Details - K132372
Device Classification Name
Indicator, Physical/Chemical Sterilization Process
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510(K) Number
K132372
Device Name
Indicator, Physical/Chemical 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
JOJ
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More FDA Info for this Product Code
Date Received
07/30/2013
Decision Date
11/26/2013
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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