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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, flexible
510(k) Number K922542
Device Name GRASPING FORCEPS
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
FGO  
Date Received05/29/1992
Decision Date 08/19/1992
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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