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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 K213194
Device Name HD Mediastinoscope
Applicant
Karl Storz Endoscopy America, Inc.
2151 E. Grand Ave
El Segundo,  CA  90245
Applicant Contact Alita McElroy
Correspondent
Karl Storz Endoscopy America, Inc.
2151 E. Grand Ave
El Segundo,  CA  90245
Correspondent Contact Alita McElroy
Regulation Number874.4720
Classification Product Code
EWY  
Date Received09/29/2021
Decision Date 06/23/2022
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
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