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FDA 510(k) Application Details - K122044
Device Classification Name
Indicator, Biological Sterilization Process
More FDA Info for this Device
510(K) Number
K122044
Device Name
Indicator, Biological Sterilization Process
Applicant
ADVANCED STERILIZATION PRODUCTS
33 TECHNOLOGY DRIVE
Irvine, CA 92618 US
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Contact
NANCY CHU
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
07/12/2012
Decision Date
10/04/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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