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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dislodger, stone, flexible
510(k) Number K914112
Device Name METAL URETERAL BASKET STONE DISLODGER, FLAT WIRE
Applicant
ANNEX MEDICAL, INC.
7887 FULLER RD. #109
EDEN PRAIRIE,  MN  55344
Applicant Contact STUART J LIND
Correspondent
ANNEX MEDICAL, INC.
7887 FULLER RD. #109
EDEN PRAIRIE,  MN  55344
Correspondent Contact STUART J LIND
Regulation Number876.4680
Classification Product Code
FGO  
Date Received09/13/1991
Decision Date 02/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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