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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 K974493
Device Name FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES
Applicant
Fiegert-Endotech Medizintechnik GmbH
Gaensaecker 42
Tuttlingen,  DE D-78532
Correspondent
Fiegert-Endotech Medizintechnik GmbH
Gaensaecker 42
Tuttlingen,  DE D-78532
Regulation Number876.1500
Classification Product Code
FDS  
Subsequent Product Codes
FAM   FDF   FDT   FEM  
Date Received11/28/1997
Decision Date 03/31/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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