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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nasopharyngoscope (flexible or rigid)
510(k) Number K200740
Device Name HD Video Rhino Laryngoscope
Applicant
KARL STORZ Endoscopy - America, Inc.
2151 E. Grand Avenue
El Segundo,  CA  90245
Applicant Contact Irina Fedorov
Correspondent
KARL STORZ Endoscopy - America, Inc.
2151 E. Grand Avenue
El Segundo,  CA  90245
Correspondent Contact Winkie Wong
Regulation Number874.4760
Classification Product Code
EOB  
Date Received03/23/2020
Decision Date 08/11/2020
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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