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Found 3 results
510(k) Data Aggregation
K Number
K002071Manufacturer
Date Cleared
2000-07-24
(17 days)
Product Code
Regulation Number
878.3300Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K962496Device Name
SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.)Manufacturer
Date Cleared
1996-09-03
(69 days)
Product Code
Regulation Number
878.3300Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.)
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
K Number
K960481Device Name
SOFT TISSUE AUGMENTATION TUBEManufacturer
Date Cleared
1996-04-01
(59 days)
Product Code
Regulation Number
878.3300Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
SOFT TISSUE AUGMENTATION TUBE
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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