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FDA 510(k) Application Details - K980868
Device Classification Name
Colonic Irrigation System
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510(K) Number
K980868
Device Name
Colonic Irrigation System
Applicant
GENTLE COLONICS, INC.
3722 AVENUE SAUSALITO
IRVINE, CA 92606-1849 US
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Contact
KAREN U SALINAS
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Regulation Number
876.5220
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Classification Product Code
KPL
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More FDA Info for this Product Code
Date Received
03/06/1998
Decision Date
08/06/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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