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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K222284
Device Name Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)
Applicant
Applied Medical Resources Corporation
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Applicant Contact Blake Stacy
Correspondent
Applied Medical Resources Corporation
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Correspondent Contact Blake Stacy
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/01/2022
Decision Date 10/14/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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