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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mediastinoscope, Surgical
510(k) Number K141622
Device Name ILLUMINATED MEDIASTINOSCOPE
Applicant
Aegis Surgical, Ltd.
113 Grantwood Dr.
Holly Springs,  NC  27540
Applicant Contact TAMMY CARREA
Correspondent
Aegis Surgical, Ltd.
113 Grantwood Dr.
Holly Springs,  NC  27540
Correspondent Contact TAMMY CARREA
Regulation Number874.4720
Classification Product Code
EWY  
Date Received06/17/2014
Decision Date 01/09/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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