FDA 510(k) Application Details - K142454

Device Classification Name Sterilizer, Chemical

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510(K) Number K142454
Device Name Sterilizer, Chemical
Applicant ADVANCED STERILIZATION PRODUCTS
33 TECHNOLOGY DR.
IRVINE, CA 92618 US
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Contact SUN CHOI
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Regulation Number 880.6860

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Classification Product Code MLR
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Date Received 09/02/2014
Decision Date 04/03/2015
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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