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510(k) Data Aggregation
K Number
K023969Device Name
REACTIVE SKIN DECONTAMINATION LOTION
Manufacturer
Date Cleared
2003-03-25
(116 days)
Product Code
Regulation Number
878.4014Why did this record match?
Product Code :
MAC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Reactive Skin Decontamination Lotion is intended to remove or neutralize chemical warfare agents and T-2 toxin from the skin.
Device Description
The RSDL lotion is pre-impregnated in a 2 x 3.9 x 0.4 inch, or 3.9 x 3.9 x 0.4 inch foam sponge applicator pad. Each applicator pad is packaged as a single unit in a heat-sealed polyethylene-lined aluminum foil pouch. The foil pouch is covered by a kraft paper outer layer to facilitate coloring of the finished package and to make opening the package possible when wearing CW protective clothing.
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