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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 K910603
Device Name LOOP RETRIEVER
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
FFL  
Date Received02/12/1991
Decision Date 03/11/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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