K Number
K961775Device Name
PROFORE FOUR-LAYER BANDAGE SYSTEM KITManufacturer
Date Cleared
1996-07-16
(69 days)
Product Code
Regulation Number
N/AType
TraditionalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A