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FDA 510(k) Application Details - K111377
Device Classification Name
Sterilizer, Chemical
More FDA Info for this Device
510(K) Number
K111377
Device Name
Sterilizer, Chemical
Applicant
ADVANCED STERILIZATION PRODUCTS
33 TECHNOLOGY DR.
IRVINE, CA 92618 US
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Contact
NANCY CHU
Other 510(k) Applications for this Contact
Regulation Number
880.6860
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Classification Product Code
MLR
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More FDA Info for this Product Code
Date Received
05/16/2011
Decision Date
09/13/2012
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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