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510(k) Data Aggregation
K Number
K964808Device Name
SPETEMPManufacturer
Date Cleared
1997-02-26
(89 days)
Product Code
Regulation Number
872.3275Type
TraditionalPanel
DentalReference & 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
K964809Device Name
SPETEMP EFManufacturer
Date Cleared
1997-01-02
(34 days)
Product Code
Regulation Number
872.3275Type
TraditionalPanel
DentalReference & 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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