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510(k) Data Aggregation
K Number
K990530Device Name
KERLIX MD ANTIMICROBIAL GAUZE DRESSING
Manufacturer
THE KENDALL COMPANY, L.P.
Date Cleared
2000-01-31
(346 days)
Product Code
NAD
Regulation Number
878.4020Why did this record match?
Applicant Name (Manufacturer) :
THE KENDALL COMPANY, L.P.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
KERUX Antimicrobial Gauze is intended for use as a primary dressing for exuding wounds, first and second degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing
Device Description
The proposed Kerlix MD Antimicrobial Gauze Dressing is a sterile, single use, wound dressing consisting of gauze treated with Polyhexamethylene Biguanide Hydrochloride. The dressing is packaged in Tyvek/Poly pouches as well as Tyvek/Styrene trays and is available in both sponge and roll form.
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K Number
K992079Device Name
KENDALL MODEL 7325 SCD RESPONSE COMPRESSION SYSTEM, MODEL 7325
Manufacturer
THE KENDALL COMPANY, L.P.
Date Cleared
1999-09-29
(100 days)
Product Code
JOW, AUG
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
THE KENDALL COMPANY, L.P.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SCD RESPONSE Compression System is designed to apply sequential compression to the lower limbs to help prevent deep vein thrombosis in patients at risk.
Device Description
The SCD Response™ Compression System is a microprocessor controlled pneumatic compression device which provides intermittent, sequentially graduated pressure to compressible limb sleeves. When the sleeves compress the legs, the veins collapse, forcing the blood to move toward the heart. After compression, the sleeves deflate, allowing the veins to take shape again and fill with blood. The full cycle then repeats again.
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