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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastroscope And Accessories, Flexible/Rigid
510(k) Number K060907
Device Name KARL STORZ VIDEO GASTROSCOPES
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE DRIVE
CULVER CITY,  CA  90230
Applicant Contact PAUL S LEE
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE DRIVE
CULVER CITY,  CA  90230
Correspondent Contact PAUL S LEE
Regulation Number876.1500
Classification Product Code
FDS  
Subsequent Product Codes
FWF   GCT  
Date Received04/03/2006
Decision Date 11/09/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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