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FDA 510(k) Application Details - K000031
Device Classification Name
Colonic Irrigation System
More FDA Info for this Device
510(K) Number
K000031
Device Name
Colonic Irrigation System
Applicant
PRIME PACIFIC HEALTH INNOVATIONS CORPORATION
145 RIVERSIDE DR.
NORTH VANCOUVER V7H 1T6 CA
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Contact
OTHMAR VOGEL
Other 510(k) Applications for this Contact
Regulation Number
876.5220
More FDA Info for this Regulation Number
Classification Product Code
KPL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/05/2000
Decision Date
09/10/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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