FDA 510(k) Application Details - K233830

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K233830
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant Medtronic Sofamor Danek USA Inc.
1800 Pyramid Place
Memphis, TN 38132 US
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Contact Jeff Sprague
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 12/01/2023
Decision Date 02/28/2024
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 K233830


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