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510(k) Data Aggregation
K Number
K031684Device Name
TOPKIN WOUND DRESSING
Manufacturer
BIOMET MERCK GMBH
Date Cleared
2003-10-30
(153 days)
Product Code
QSZ, FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BIOMET MERCK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For temporary coverage of non-infected skin defects, such as superficial wounds, under sterile conditions.
Device Description
Topkin® foil is a synthetic, polymeric, transparent foil for temporary coverage of non-infected skin defects, such as superficial wounds, under sterile conditions.
Topkin® adhesive is made from the same ingredients like the Topkin® foil plus Titanium dioxide and is used for the fixation of Topkin® foil on healthy skin. The fixation is mediated by cohesive forces between the Topkin® foil, the Topkin® adhesive and the healthy skin.
Material used:
Topkin® foil: Lactide-caprolactone copolymers
Topkin® Adhesive: 99 % Oligocaprolactone-co-lactide and 1 % Titanium dioxide
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