FDA 510(k) Application Details - K233425

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K233425
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant Sutter Medizintechnik GmbH
Alfred-Walz-Str. 22
Emmendingen 79312 DE
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Contact Simone Peschl
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 10/11/2023
Decision Date 01/25/2024
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 K233425


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