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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 K891253
Device Name UROLOGICAL GRASPING FORCEPS
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
FGO  
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
Predetermined Change
Control Plan Authorized		 No
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