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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology
510(k) Number K012660
Device Name GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES
Applicant
Gimmi GmbH
Amstel 320-I
Amsterdam, Nh,  NL 1017AP
Applicant Contact DAGMAR MASER
Correspondent
Gimmi GmbH
Amstel 320-I
Amsterdam, Nh,  NL 1017AP
Correspondent Contact DAGMAR MASER
Regulation Number876.1500
Classification Product Code
FET  
Subsequent Product Codes
EZO   FAJ   FAS   FBK   FBM  
FCL   FDC   FDE   FED   FGC   FHA  
FJL   GBZ   GCJ   GCT   GEI   KNS  
KOA   KOD   KOE   KQT   LQR  
Date Received08/13/2001
Decision Date 12/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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