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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 K951532
Device Name METAL URETERAL BASKET STONE DISLODGER
Applicant
Annex Medical, Inc.
7098 Shady Oak Rd.
Eden Prairie,  MN  55344
Applicant Contact EUGENE C KARELS
Correspondent
Annex Medical, Inc.
7098 Shady Oak Rd.
Eden Prairie,  MN  55344
Correspondent Contact EUGENE C KARELS
Regulation Number876.4680
Classification Product Code
FFL  
Date Received04/03/1995
Decision Date 07/19/1995
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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