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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 K000031
Device Name AQUANET, MODEL EC 2000
Applicant
PRIME PACIFIC HEALTH INNOVATIONS CORPORATION
145 RIVERSIDE DR.
NORTH VANCOUVER,  CA V7H 1T6
Applicant Contact OTHMAR VOGEL
Correspondent
PRIME PACIFIC HEALTH INNOVATIONS CORPORATION
145 RIVERSIDE DR.
NORTH VANCOUVER,  CA V7H 1T6
Correspondent Contact OTHMAR VOGEL
Regulation Number876.5220
Classification Product Code
KPL  
Date Received01/05/2000
Decision Date 09/10/2001
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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