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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonic Irrigation System
510(k) Number K891585
Device Name HYDRO-SAN COLONIC IRRIGATION SYSTEM
Applicant
Specialty Health Products, Inc.
21636 N. 14th Ave.
Suite A-1
Phoenix,  AZ  85027
Applicant Contact Deborah Solomon
Correspondent
Specialty Health Products, Inc.
21636 N. 14th Ave.
Suite A-1
Phoenix,  AZ  85027
Correspondent Contact Stephen Collins
Regulation Number876.5220
Classification Product Code
KPL  
Date Received03/20/1989
Decision Date 08/03/1989
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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