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510(k) Data Aggregation
K Number
K013696Device Name
SILMED NASAL SEPTAL BUTTON
Manufacturer
SILMED, INC.
Date Cleared
2001-11-28
(21 days)
Product Code
LFB
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SILMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Silmed Nasal Septal Button is indicated for use for non-surgical closure of nasal septum perforations.
Device Description
Silmed, Inc. Nasal Septal Button is indicated for use for non-surgical closure of nasal perforations. The Silmed Nasal Septal Button is designed in three sizes: small, medium and large. The Silmed Nasal Septal Button features two circular flanges centrally comected by a post. The circular flanges come in varying diaments depending on the size of the button. The central post is elliptical in shape and can also be explained as an elongated circular section. The post dimensions vary with size and with the circular flange diameter based on the size of the nasal perforation and can be trimmed at the time of placement.
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