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510(k) Data Aggregation
K Number
K973538Device Name
N-TERFACE
Manufacturer
WINFIELD LABORATORIES, INC.
Date Cleared
1997-12-16
(89 days)
Product Code
MGP
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
WINFIELD LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
N-TERFACE Interpositional Surfacing Material is indicated for use as a wound contact layer for partial thickness burns and and confection worselves of laser skin resurfacing. indicated for use as a wound concace in ......................................................................................................................................
Device Description
N-TERFACE® Interpositional Surfacing Material is an extruded, non-woven, high density polyethylene sheeting material with the following physical properties: Weight, oz/yd2: 0.36 to 0.8, Thickness, Mils: 4.0 to 5.0, Tensile, Ibs/in .: roll direction 14 to 77, cross direction 1.5 to 4.5, Air Permeability ft3/min/ft2: 545 to 1144.
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