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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 K831875
Device Name BALLOON DILATION HELICAL STONE EXTRACT
Applicant
Vpi
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Vpi
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.4680
Classification Product Code
FFL  
Date Received06/13/1983
Decision Date 09/12/1983
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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