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Found 10 results
510(k) Data Aggregation
K Number
K955685Device Name
RNS STERILE, DISPOSABLE CT BIOPSY TRAYManufacturer
Date Cleared
1996-10-04
(295 days)
Product Code
Regulation Number
870.1650Type
TraditionalPanel
CardiovascularReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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K Number
K962040Device Name
RNS ARTHROGRAM TRAYManufacturer
Date Cleared
1996-06-25
(32 days)
Product Code
Regulation Number
880.5570Type
TraditionalPanel
General HospitalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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AI/ML Overview
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K Number
K955687Manufacturer
Date Cleared
1996-06-03
(172 days)
Product Code
Regulation Number
892.1650Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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AI/ML Overview
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K Number
K955689Manufacturer
Date Cleared
1996-05-15
(153 days)
Product Code
Regulation Number
870.4500Type
TraditionalPanel
CardiovascularReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
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K Number
K955684Device Name
RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAYManufacturer
Date Cleared
1996-05-02
(140 days)
Product Code
Regulation Number
870.1650Type
TraditionalPanel
CardiovascularReference & 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
K955679Device Name
RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAYManufacturer
Date Cleared
1996-03-12
(89 days)
Product Code
Regulation Number
884.1550Type
TraditionalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
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K Number
K955678Device Name
RNS STERILE DISPOSABLE PUNCTURE TRAYManufacturer
Date Cleared
1996-02-21
(69 days)
Product Code
Regulation Number
880.6850Type
TraditionalPanel
General HospitalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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K Number
K955688Device Name
RNS STERILE, DISPOSABLE STANDARD BIOPSY TRAYManufacturer
Date Cleared
1996-02-21
(69 days)
Product Code
Regulation Number
880.6850Type
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
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K Number
K955686Manufacturer
Date Cleared
1996-02-21
(69 days)
Product Code
Regulation Number
880.6850Type
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
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K Number
K955683Manufacturer
Date Cleared
1996-02-01
(49 days)
Product Code
Regulation Number
878.4800Type
TraditionalReference & 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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