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510(k) Data Aggregation
K Number
K003270Manufacturer
Date Cleared
2000-12-22
(65 days)
Product Code
Regulation Number
892.5700Type
SpecialPanel
RadiologyReference & Predicate Devices
N/A
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Device Name :
PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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