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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 K050112
Device Name PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117
Applicant
Prime Pacific Health Innovations Corporation
8-145 Riverside Dr.
North Vancouver, Bc,  CA V7H 1T6
Applicant Contact DELMAR VOGEL
Correspondent
Prime Pacific Health Innovations Corporation
8-145 Riverside Dr.
North Vancouver, Bc,  CA V7H 1T6
Correspondent Contact DELMAR VOGEL
Regulation Number876.5220
Classification Product Code
KPL  
Date Received01/18/2005
Decision Date 03/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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