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FDA 510(k) Application Details - K232918
Device Classification Name
Accessories, Germicide, Cleaning, For Endoscopes
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510(K) Number
K232918
Device Name
Accessories, Germicide, Cleaning, For Endoscopes
Applicant
Steris Corporation
5960 Heisley Road
Mentor, OH 44060 US
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Contact
Nalepka Jennifer
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
NZA
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More FDA Info for this Product Code
Date Received
09/19/2023
Decision Date
10/03/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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