FDA 510(k) Application Details - K232951

Device Classification Name Endoscope Channel Accessory

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510(K) Number K232951
Device Name Endoscope Channel Accessory
Applicant Steris
5976 Heisley Rd
Mentor, OH 44060 US
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Contact Carroll Martin
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Regulation Number 876.1500

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Classification Product Code ODC
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Date Received 09/21/2023
Decision Date 10/20/2023
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 K232951


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