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FDA 510(k) Application Details - K954142
Device Classification Name
Sterilizer, Steam
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510(K) Number
K954142
Device Name
Sterilizer, Steam
Applicant
ADVANCED STERILIZATION PRODUCTS
33 TECHNOLOGY DR.
IRVINE, CA 92618 US
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Contact
KEVIN CORRIGAN
Other 510(k) Applications for this Contact
Regulation Number
880.6880
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Classification Product Code
FLE
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More FDA Info for this Product Code
Date Received
09/01/1995
Decision Date
06/06/1997
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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