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510(k) Data Aggregation
K Number
K011395Manufacturer
Date Cleared
2001-07-12
(66 days)
Product Code
Regulation Number
870.3800Type
SpecialPanel
CardiovascularReference & Predicate Devices
N/A
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Device Name :
MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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