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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 K202818
Device Name Voyant Fine Fusion Device (EB230)
Applicant
Applied Medical
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Applicant Contact Blake Stacy
Correspondent
Applied Medical
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Correspondent Contact Blake Stacy
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/24/2020
Decision Date 12/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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