BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    HA ABSORBENT WOUND DRESSING

    K Number: K984388 · Decision Mar 3, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    187
    Applicant Total
    81
    Review Days
    85

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    Basic Information

    Device Name
    HA ABSORBENT WOUND DRESSING
    K Number
    K984388
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Convatec, A Division of E.R. Squibb & Sons
    Date Received
    December 8, 1998
    Decision Date
    March 3, 1999
    Product Code
    KGN
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KGN Wound Dressing With Animal-Derived Material(S)

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    Other Clearances by Convatec, A Division of E.R. Squibb & Sons

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    K980382 NON-WOVEN COMPRESS
    K974823 NONWOVEN DRESSING
    K974205 KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON
    K974304 GERMICIDAL CLOTH
    K973632 DUODERM CGF CONTROL GEL FORMULA DRESSING
    K972530 CONVATEC ODOR CONTROL WOUND DRESSING
    K972062 CONVATEC NON-ADHESIVE DRESSING
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