FDA 510(k) Application Details - K231146

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K231146
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant Alic Iotech, LLC
8165 Mountain View Dr Unit D
Pleasanton, CA 94588 US
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Contact Like Zeng
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 04/21/2023
Decision Date 09/08/2023
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



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