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510(k) Data Aggregation
K Number
K964614Device Name
ULTRAFERA WOUND DRESSINGManufacturer
Date Cleared
1997-02-06
(80 days)
Product Code
Regulation Number
880.5090Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN WHITE CROSS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K962400Device Name
AIR MAX EXTERNAL NASAL DILATOR STRIPManufacturer
Date Cleared
1996-09-09
(80 days)
Product Code
Regulation Number
874.3900Type
TraditionalPanel
Ear Nose & ThroatReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN WHITE CROSS, INC.
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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