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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K212656
Device Name Flexible Intubation Video Endoscope – Sterile (FIVE-S)
Applicant
KARL STORZ Endoscopy America
2151 E. Grand Avenue
El Segundo,  CA  90245
Applicant Contact Mario Trujillo
Correspondent
KARL STORZ Endoscopy America
2151 E. Grand Avenue
El Segundo,  CA  90245
Correspondent Contact Mario Trujillo
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received08/23/2021
Decision Date 12/29/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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