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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 K891254
Device Name UROLOGICAL STONE BASKET
Applicant
NORTHGATE RESEARCH, INC.
3930 VENTURA DR.
SUITE 400
ARLINGTON HEIGHTS,  IL  60004
Applicant Contact CHARLES P GILL
Correspondent
NORTHGATE RESEARCH, INC.
3930 VENTURA DR.
SUITE 400
ARLINGTON HEIGHTS,  IL  60004
Correspondent Contact CHARLES P GILL
Regulation Number876.4680
Classification Product Code
FFL  
Date Received03/08/1989
Decision Date 03/22/1989
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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