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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 K071530
FOIA Releasable 510(k) K071530
Device Name KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Applicant Contact SUSIE CHEN
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Correspondent Contact SUSIE CHEN
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received06/05/2007
Decision Date 08/24/2007
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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