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510(k) Data Aggregation
K Number
K003194Device Name
STACKHOUSE LENS HOOD, MODEL SA-700/FSManufacturer
Date Cleared
2000-10-26
(14 days)
Product Code
Regulation Number
878.4040Type
SpecialPanel
General HospitalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K000605Device Name
STACKHOUSE LENS HOOD, MODEL SA-700/FManufacturer
Date Cleared
2000-08-17
(176 days)
Product Code
Regulation Number
878.4040Type
TraditionalPanel
General HospitalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
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