FDA 510(k) Application Details - K002401

Device Classification Name Sterilant, Medical Devices

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510(K) Number K002401
Device Name Sterilant, Medical Devices
Applicant ADVANCED STERILIZATION PRODUCTS
33 TECHNOLOGY DR.
IRVINE, CA 92618 US
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Contact NEELU MEDHEKER
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Regulation Number 880.6885

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Classification Product Code MED
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Date Received 08/07/2000
Decision Date 08/29/2000
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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