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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Irrigation, Urological
510(k) Number K941385
Device Name PRO PULSE SYRINGE IRRIGATION SYSTEM
Applicant
Giesy Consultants, Inc.
501 N. Graham St.
Suite 420
Portland,  OR  97227
Applicant Contact MATTHEW W HOSKINS
Correspondent
Giesy Consultants, Inc.
501 N. Graham St.
Suite 420
Portland,  OR  97227
Correspondent Contact MATTHEW W HOSKINS
Regulation Number876.5130
Classification Product Code
LJH  
Date Received03/22/1994
Decision Date 06/09/1994
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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