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510(k) Data Aggregation
K Number
K091135Device Name
RUTTER SUPRA STOMAL STENTS
Manufacturer
BOSTON MEDICAL PRODUCTS, INC.
Date Cleared
2009-09-14
(147 days)
Product Code
FWN
Regulation Number
874.3620Why did this record match?
Product Code :
FWN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rutler Supra Stomal Stent is indicated for the prevention and treatment of laryngeal and tracheal stenosis.
Device Description
Not Found
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K Number
K000154Device Name
ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1
Manufacturer
E. BENSON HOOD LAB, INC.
Date Cleared
2000-03-29
(70 days)
Product Code
FWN
Regulation Number
874.3620Why did this record match?
Product Code :
FWN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K962693Device Name
MONTGOMERY RADIOPAQUE LARYNGEAL KEEL
Manufacturer
BOSTON MEDICAL PRODUCTS, INC.
Date Cleared
1996-08-09
(29 days)
Product Code
FWN
Regulation Number
874.3620Why did this record match?
Product Code :
FWN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. To repair simple anterior glottic stenosis due to anterior commissure web formation.
2. To prevent anterior glottic stenosis in situations where anterior commissure stenosis is likely to occur (eg, following extralaryigeal or endolaryngeal trauma with loss of anterior commissure).
3. To prevent the anterior glottic stenosis immediately following removal of the Montgomery Laryngeal Stent.
Device Description
The Laryngeal Keel is an umbrella-shaped device designed to the anatomy of the anterior commissure. The keel is available is sizes 12mm, 14mm, and 16mm.
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