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510(k) Data Aggregation
K Number
K000388Manufacturer
Date Cleared
2000-08-08
(183 days)
Product Code
Regulation Number
876.5220Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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