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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 K914505
Device Name STONE BASKET
Applicant
SURGITEK MEDICAL ENGINEERING CORP.
3037 MT. PLEASANT ST.
RACINE,  WI  53404
Applicant Contact BRIAN KUNST
Correspondent
SURGITEK MEDICAL ENGINEERING CORP.
3037 MT. PLEASANT ST.
RACINE,  WI  53404
Correspondent Contact BRIAN KUNST
Regulation Number876.4680
Classification Product Code
FFL  
Date Received10/09/1991
Decision Date 12/09/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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