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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 K954797
Device Name KARL STORZ RHINO-LARYNGO-BRONCHO FIBERSCOPE, FIBERSCOPE FOR BRONCHOSCOPY
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Applicant Contact RENATE A MACLAREN
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Correspondent Contact RENATE A MACLAREN
Regulation Number874.4680
Classification Product Code
EOQ  
Subsequent Product Code
EOB  
Date Received10/18/1995
Decision Date 01/17/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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