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    FDA 510(k) FDA unclassified Substantially Equivalent 🇹🇼 Taiwan

    CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING

    K Number: K123394 · Decision Jun 6, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    9
    Review Days
    216

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    Basic Information

    Device Name
    CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING
    K Number
    K123394
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Coreleader Biotech Co., Ltd.
    Date Received
    November 2, 2012
    Decision Date
    June 6, 2013
    Product Code
    FRO
    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
    FRO Dressing, Wound, Drug

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    Other Clearances by Coreleader Biotech Co., Ltd.

    K Number Device Name
    K151204 HEMO-Bandage
    K141382 BIOS KING BIOCELLULOSE FILM
    K111578 CORELEADER COLLA-ALGI FIBER MODEL CAW
    K111733 CORELEADER SCAR-DIMMER
    K102944 CORELEADER HEMO-PAD MODEL CPII 02030
    K102942 CORELEADER ALGIPLASTER MODEL AP 050501
    K102946 CORELEADER COLLA-PAD MODEL CS 03030
    K102943 CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050