FDA 510(k) Application Details - K240098

Device Classification Name Endoscope Channel Accessory

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510(K) Number K240098
Device Name Endoscope Channel Accessory
Applicant Steris Corporation
5960 Heisley Road
Mentor, OH 44060 US
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Contact Jackie Oliver
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Regulation Number 876.1500

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Classification Product Code ODC
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Date Received 01/12/2024
Decision Date 02/09/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K240098


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