BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DUODERM HYDROCOLLOID GEL

    K Number: K931618 · Decision Dec 10, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    292
    Registration Numbers
    292
    Same Product Code
    28
    Applicant Total
    81
    Review Days
    252

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    Basic Information

    Device Name
    DUODERM HYDROCOLLOID GEL
    K Number
    K931618
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4022
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Convatec, A Division of E.R. Squibb & Sons
    Date Received
    April 2, 1993
    Decision Date
    December 10, 1993
    Product Code
    NAE
    Advisory Committee
    General, Plastic Surgery
    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
    NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic

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

    K Number Device Name
    K013814 ABSORBENT ANTIMICROBIAL WOUND DRESSING
    K990964 SIGNADRESS DUODERM DRESSING
    K984388 HA ABSORBENT WOUND DRESSING
    K980720 NONWOVEN PAD
    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
    Search all 81 clearances from Convatec, A Division of E.R. Squibb & Sons →