BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE

    K Number: K960045 · Decision Jun 5, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    9
    Review Days
    155

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    Basic Information

    Device Name
    ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE
    K Number
    K960045
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Sewing Source, Inc.
    Date Received
    January 2, 1996
    Decision Date
    June 5, 1996
    Product Code
    KKX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KKX Drape, Surgical, Antimicrobial

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    Other Clearances by The Sewing Source, Inc.

    K Number Device Name
    K921152 O.R./SURGEONS GOWN, ITEM NO. 4952
    K921151 O.R./SURGEONS GOWN, ITEM NO. 4951
    K921153 O.R./SURGEONS GOWN, ITEM NO. 4960
    K921155 O.R./SURGEONS GOWN, ITEM NO. 4962
    K921157 O.R./SURGEONS GOWN, ITEM NO. 4942
    K921154 O.R./SURGEONS GOWN, ITEM NO. 4962
    K921158 O.R./SURGEONS GOWN, ITEM NO. 4950
    K921156 O.R./SURGEONS GOWN, ITEM NO.4941