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510(k) Data Aggregation
K Number
K060037Device Name
FITPACK
Manufacturer
Date Cleared
2006-07-25
(200 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
ASP PLASTICS PTY LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Fitpack® DS-128 and DS-130 Fit Tank Products are intended to be used for the collection, transportation and disposal of hypodermic needles and syringes in health care areas, home care environment and any other area requiring the use of sharps containers for the collection, transportation and disposal of used hypodermic needles and syringes.
The Fitpack® DS-047 Disposa Safe Clean Up, DS-091 Disposa Safe Products are intended to be used for the collection, transportation and disposal of 1 ml insulin hypodermic needles and syringes in health care arcas, home care environment and any other area requiring the use of sharps containers for the collection, transportation and disposal of used 1 ml insulin hypodermic needles and syringes.
The Fitpack® DS-046 mini fit tube Product is intended to be used for the collection, transportation and disposal of 1 ml and 2 ml hypodermic needles and syringes in health care areas, home care environment and any other area requiring the use of sharps containers for the collection, transportation and disposal of used 1 ml and 2 ml hypodermic needles and syringes.
Device Description
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