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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 K871779
Device Name HELICAL STONE BASKET (DISPOSABLE)
Applicant
VAN-TEC, INC.
P.O. BOX 26
SPENCER,  IN  47460
Applicant Contact JAMES F VANCE
Correspondent
VAN-TEC, INC.
P.O. BOX 26
SPENCER,  IN  47460
Correspondent Contact JAMES F VANCE
Regulation Number876.4680
Classification Product Code
FFL  
Date Received05/06/1987
Decision Date 06/17/1987
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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