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FDA 510(k) Application Details - K240098
Device Classification Name
Endoscope Channel Accessory
More FDA Info for this Device
510(K) Number
K240098
Device Name
Endoscope Channel Accessory
Applicant
Steris Corporation
5960 Heisley Road
Mentor, OH 44060 US
Other 510(k) Applications for this Company
Contact
Jackie Oliver
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
ODC
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More FDA Info for this Product Code
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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