FDA 510(k) Application Details - K230432

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K230432
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant HG Innovations Ltd
5 Elder Court, Lions Drive
Shadsworth Business Park, Blackburn
Lancashire BB1 2EQ GB
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Contact Dr.M Umran Rafiq
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 02/17/2023
Decision Date 05/18/2023
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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