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510(k) Data Aggregation
K Number
K000438Device Name
MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER
Manufacturer
BIOSURGICAL CORP.
Date Cleared
2000-05-03
(83 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
BIOSURGICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000048Device Name
SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1
Manufacturer
BIOSURGICAL CORP.
Date Cleared
2000-01-31
(24 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
BIOSURGICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K992351Device Name
SEALOUETTE FIBRIN SEALANT APPLICATOR
Manufacturer
BIOSURGICAL CORP.
Date Cleared
1999-10-08
(86 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
BIOSURGICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the mixing, and one-to-one (1:1) delivery, of fibrin sealant for medical applications. It can also be attached to standard hospital wall suction for removal of debris, excess tissue or foreign particles in the wound.
Device Description
The Sealouette™ Fibrin Sealant Applicator is intended for the mixing and delivery of fibrin sealant for medical applications. It can also be attached to standard hospital wall suction for removal of fluid debris, excess tissue or foreign particles in the wound.
The Sealouette™ Fibrin Sealant Applicator consists of the main housing, which holds the dual chamber syringe barrel and a common plunger that provides for the delivery and mixture of equal volumes of the two-part fibrin sealant through a mixing chamber and application lumen.
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K Number
K964597Device Name
BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE
Manufacturer
BIOSURGICAL CORP.
Date Cleared
1997-09-08
(294 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
BIOSURGICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BioSurgical Corp. Multi Chamber Suction Syringe is indicated for the mixing and application of FDA approved fluids to wounds, the delivery of antibiotics, and other wound treatment fluids. It can also be attached to standard hospital wall suction for removal of fluid debris, excess tissue or foreign particles in the wound.
Device Description
Multi Chamber Suction Syringe
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