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Found 4 results
510(k) Data Aggregation
K Number
K131745Device Name
BLOM-SINGER SEPTAL PERFORATION PROSTHESIS
Manufacturer
HELIX MEDICAL, LLC
Date Cleared
2013-09-17
(96 days)
Product Code
LFB
Regulation Number
N/AWhy did this record match?
Product Code :
LFB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Blom-Singer® Septal Perforation Prosthesis is indicated for use for non-surgical closure of nasal septum perforations.
Device Description
The Blom-Singer® Septal Perforation Prosthesis is a bi-flanged elastomeric device, each prosthesis are comprised of two (2) pieces which are attached to one another using a set of 2 enclosed magnets at the center of the flanges. The center post is either an oval or circular silicone stem that will fill most of the nasal septal perforation. The overlapping thin section or flange will extend beyond perforation to help with the closure of the perforation and the retention of the device.
The flanges will be offered is various sizes and shapes to accommodate the individual's septal shape. In addition, the clinician may trim the flanges to fit.
The device is intended to be used up to 29 days.
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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?
Product Code :
LFB
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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K Number
K982667Device Name
MICROMEDICS NASAL SEPTAL BUTTON
Manufacturer
MICROMEDICS, INC.
Date Cleared
1998-11-24
(116 days)
Product Code
LFB
Regulation Number
N/AWhy did this record match?
Product Code :
LFB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Non-surgical closure of nasal septum perforation
Device Description
Not Found
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K Number
K972060Device Name
NASAL SEPTAL BUTTON
Manufacturer
BOSTON MEDICAL PRODUCTS, INC.
Date Cleared
1997-07-03
(31 days)
Product Code
LFB
Regulation Number
N/AWhy did this record match?
Product Code :
LFB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used for non-surgical closure of nasal perforations.
Device Description
The Nasal Septal Button is designed for non-surgical closure of septal perforations. The device is manufactured using soft medical grade silicone and can be trimmed at the time of placement. Studies have shown that use of a nasal septal button has decreased symptoms of nasal perforations including epistaxis and crusting. The button features two 3.2cm diameter flanges connected by a central 7mm diameter post.
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