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510(k) Data Aggregation

    K Number
    K964041
    Device Name
    CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS
    Manufacturer
    ROBERT R. STEVENS
    Date Cleared
    1997-01-30

    (114 days)

    Product Code
    KOC
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROBERT R. STEVENS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cutaneous Compression Device for Use in Hemodialysis.
    Device Description
    Cutaneous Compression Device for Use in Hemodialysis.
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    K Number
    K955270
    Device Name
    TAPE & BANDAGE, ADHESIVE
    Manufacturer
    ROBERT R. STEVENS
    Date Cleared
    1996-08-08

    (267 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROBERT R. STEVENS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cutaneous Compression Device for General Hospital Use.
    Device Description
    Tape and Bandage, Adhesive
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