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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name image, illumination, fiberoptic, for endoscope
510(k) Number K061622
Device Name PS SERIES
Applicant
PHOTONIC OPTISCHE GERATE GESMBH & COKG
SEEBOCKGASSE 59
VIENNA,  AT A-1160
Applicant Contact DIETER FEGER
Correspondent
TUV AMERICA, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number876.1500
Classification Product Code
FFS  
Subsequent Product Codes
FCW   GCT  
Date Received06/12/2006
Decision Date 03/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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