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FDA 510(k) Application Details - K220404
Device Classification Name
Sterilizer, Chemical
More FDA Info for this Device
510(K) Number
K220404
Device Name
Sterilizer, Chemical
Applicant
Advanced Sterilization Products, Inc.
33 Technology Drive
Irvine, CA 92618 US
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Contact
Katy Nennig
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
02/14/2022
Decision Date
05/16/2022
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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