FDA 510(k) Application Details - K140977

Device Classification Name Accessories, Cleaning, For Endoscope

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510(K) Number K140977
Device Name Accessories, Cleaning, For Endoscope
Applicant ADVANCED STERILIZATION PRODUCTS
33 TECHNOLOGY DR.
IRVINE, CA 92618 US
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Contact REUBEN LAWSON
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Regulation Number 876.1500

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Classification Product Code FEB
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Date Received 04/16/2014
Decision Date 12/22/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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