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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 K143517
Device Name Voyant Open Sealer-Divider Device
Applicant
APPLIED MEDICAL RESOURCES
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Applicant Contact Jessica Cho
Correspondent
APPLIED MEDICAL RESOURCES
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Correspondent Contact Jessica Cho
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/12/2014
Decision Date 03/27/2015
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
Recalls CDRH Recalls
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