FDA 510(k) Application Details - K201212

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K201212
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant Applied Medical Resources Corp.
22872 Avenida Empresa
Rancho Santa Margarita, CA 92688 US
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Contact Sherif Nakhla
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 05/05/2020
Decision Date 06/05/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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