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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lithotriptor, Electro-Hydraulic
510(k) Number K852874
Device Name 5F ELECTRODE(LITHOTRIPTOR)
Applicant
NORTHGATE RESEARCH, INC.
P.O. BOX 978
PLATTSBURGH,  NJ  12901
Applicant Contact JAMES A COCHIE
Correspondent
NORTHGATE RESEARCH, INC.
P.O. BOX 978
PLATTSBURGH,  NJ  12901
Correspondent Contact JAMES A COCHIE
Regulation Number876.4480
Classification Product Code
FFK  
Date Received07/08/1985
Decision Date 08/21/1985
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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