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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, Basket, Ureteral, Metal
510(k) Number K934636
Device Name ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR
Applicant
ANNEX MEDICAL, INC.
7098 SHADY OAK RD.
EDEN PRAIRIE,  MN  55344
Applicant Contact STUART J LIND
Correspondent
ANNEX MEDICAL, INC.
7098 SHADY OAK RD.
EDEN PRAIRIE,  MN  55344
Correspondent Contact STUART J LIND
Regulation Number876.4680
Classification Product Code
FFL  
Date Received09/27/1993
Decision Date 02/25/1994
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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