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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 K864904
Device Name 3F ELECTRODE
Applicant
Northgate Research, Inc.
Franklyn Bldg.
Rt. 9 N., P.O. Box 978
Plattsburgh,  NY  12901
Applicant Contact JAMES A COCHIE
Correspondent
Northgate Research, Inc.
Franklyn Bldg.
Rt. 9 N., P.O. Box 978
Plattsburgh,  NY  12901
Correspondent Contact JAMES A COCHIE
Regulation Number876.4480
Classification Product Code
FFK  
Date Received12/15/1986
Decision Date 02/10/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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