FDA 510(k) Application Details - K241055

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K241055
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant Steris
5960 Heisley Road
Mentor, OH 44060-1834 US
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Contact Steve Elliott
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 04/17/2024
Decision Date 05/31/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K241055


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