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510(k) Data Aggregation
K Number
K982260Device Name
MARKWELL GAUZE SPONGE
Manufacturer
MARKWELL INTL., INC.
Date Cleared
1998-08-12
(47 days)
Product Code
LWH, EFO
Regulation Number
880.2740Why did this record match?
Applicant Name (Manufacturer) :
MARKWELL INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Markwell Gauze Sponges are nonsterile and for external use. It is supplied in bulk package (100/200pcs per package). To use it, simply apply the gauze pad to the area and change it when wet, or more often if needed.
Markwell Gauze Sponges may be repacked and sterilized by domestic manufacturer. If so, users have to follow the manufacturer's instructions to use it.
Device Description
Markwell Gauze Sponges are nonsterile and for external use. It is supplied in bulk package (100/200pcs per package).
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