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FDA 510(k) Application Details - K181472
Device Classification Name
Accessories, Cleaning, For Endoscope
More FDA Info for this Device
510(K) Number
K181472
Device Name
Accessories, Cleaning, For Endoscope
Applicant
Advanced Sterilization Products (ASP)
33 Technology Drive
Irvine, CA 92618 US
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Contact
Andrea L. Ruth
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FEB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/04/2018
Decision Date
04/23/2019
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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