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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 K961178
Device Name KARL STORZ INTUBATION FIBERSCOPE
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  
Date Received03/26/1996
Decision Date 05/14/1996
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
Predetermined Change
Control Plan Authorized		 No
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