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510(k) Data Aggregation
K Number
K082208Device Name
DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER
Manufacturer
SCIVOLUTIONS, INC.
Date Cleared
2008-12-01
(118 days)
Product Code
NAC
Regulation Number
878.4018Why did this record match?
Applicant Name (Manufacturer) :
SCIVOLUTIONS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Doctors choice bandage with spray on remover is intended for prescription use in the local management of pressure sores as prescribed by a medical professional.
Device Description
The SciVolutions, Doctors Choice slow healing bandage is comprised of three products. The first is a premium gauze bandage with a non-stick net bottom side and a hydropholic breathable, waterproof polyurethane film membrane top side. The second device is a nonstick hydrocolloid bandage with the same polyurethane film membrane top side. Both of these bandage types are packaged for general use or diabetic use, with the only difference being the carton and carton labeling. The third product is the spray on remover, which may be used with both products.
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K Number
K020318Device Name
SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES
Manufacturer
SCIVOLUTIONS, INC
Date Cleared
2003-02-03
(369 days)
Product Code
FRO, MXE
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SCIVOLUTIONS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Antibacterial Adhesive Bandages are to be applied to the skin for topical application. The bandages help provide an antibacterial barrier for minor cuts and scrapes.
Device Description
Antibacterial adhesive bandages are similar to many pre-amendment and already cleared products with benzalkonium chloride. They are provided in various sizes in a box for over the counter purchase. The benzalkonium chloride concentration is 1%.
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