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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, irrigation
510(k) Number K955339
Device Name HYDROLOGY 5000
Applicant
NORTHGATE TECHNOLOGIES, INC.
600 CHURCH RD.
ELGIN,  IL  60123
Applicant Contact CASEY KUREK
Correspondent
NORTHGATE TECHNOLOGIES, INC.
600 CHURCH RD.
ELGIN,  IL  60123
Correspondent Contact CASEY KUREK
Regulation Number878.4200
Classification Product Code
GBX  
Date Received11/20/1995
Decision Date 03/13/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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