FDA 510(k) Application Details - K223369

Device Classification Name Unit, Cryosurgical, Accessories

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510(K) Number K223369
Device Name Unit, Cryosurgical, Accessories
Applicant STERIS Corporation
5960 Heisley Road
Mentor, OH 44060 US
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Contact Carroll Martin
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Regulation Number 878.4350

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Classification Product Code GEH
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Date Received 11/04/2022
Decision Date 12/02/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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