FDA 510(k) Application Details - K240274

Device Classification Name

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510(K) Number K240274
Device Name PADLOCK CLIP EFTR Kit (00713229)
Applicant STERIS Corporation
5960 Heisley Road
Mentor, OH 44060 US
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Contact Jackie Oliver
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Regulation Number

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Classification Product Code PKL
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Date Received 01/31/2024
Decision Date 09/17/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K240274


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