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FDA 510(k) Application Details - K094022
Device Classification Name
Colonic Irrigation System
More FDA Info for this Device
510(K) Number
K094022
Device Name
Colonic Irrigation System
Applicant
CLEARWATER PRODUCTS, LLC
1468 HARWELL AVE.
CROFTON, MD 21114 US
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Contact
E.J. Smith
Other 510(k) Applications for this Contact
Regulation Number
876.5220
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Classification Product Code
KPL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/30/2009
Decision Date
06/11/2010
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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