K Number
K001234Device Name
BIOINSULATED SILICONE PUNCTUM PLUGManufacturer
Date Cleared
2000-07-11
(85 days)
Product Code
Regulation Number
N/AType
TraditionalPanel
OPReference & 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