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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 K933260
Device Name HELICAL STONE/FLATWIRE STONE BASKETS
Applicant
SURGITEK
3037 MT. PLEASANT ST.
RACINE,  WI  53404
Applicant Contact BRIAN KUNST
Correspondent
SURGITEK
3037 MT. PLEASANT ST.
RACINE,  WI  53404
Correspondent Contact BRIAN KUNST
Regulation Number876.4680
Classification Product Code
FFL  
Date Received07/06/1993
Decision Date 01/11/1994
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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