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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscope, neurological
510(k) Number K002788
Device Name KSEA NEURO-FIBERSCOPE
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Applicant Contact KEVIN KENNAN
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Correspondent Contact KEVIN KENNAN
Regulation Number882.1480
Classification Product Code
GWG  
Date Received09/07/2000
Decision Date 10/23/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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