LogoFDA 510(k) Search
Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K970966
    Device Name
    COMFORT CATH CHOICE MALE EXTERNAL CATHETER
    Manufacturer
    SIERRA LABORATORIES, INC.
    Date Cleared
    1997-04-22

    (36 days)

    Product Code
    EXJ
    Regulation Number
    876.5250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIERRA LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K962384
    Device Name
    COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER
    Manufacturer
    SIERRA LABORATORIES, INC.
    Date Cleared
    1996-07-15

    (25 days)

    Product Code
    EXJ
    Regulation Number
    876.5250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIERRA LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K962413
    Device Name
    COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER
    Manufacturer
    SIERRA LABORATORIES, INC.
    Date Cleared
    1996-07-15

    (24 days)

    Product Code
    EXJ
    Regulation Number
    876.5250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIERRA LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1