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

    STERILE SURGEON'S GOWN, MODIFICATION

    K Number: K931144 · Decision Jun 10, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    12
    Review Days
    462

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    Basic Information

    Device Name
    STERILE SURGEON'S GOWN, MODIFICATION
    K Number
    K931144
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Amsco Sterile Recoveries, Inc.
    Date Received
    March 5, 1993
    Decision Date
    June 10, 1994
    Product Code
    FYA
    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
    FYA Gown, Surgical

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    Other Clearances by Amsco Sterile Recoveries, Inc.

    K Number Device Name
    K932522 AMSCO STERILE RECOVERIES SURGICAL PACKS
    K931143 AMSCO STERILE RECOVERIES ABSORBENT TOWELS
    K931146 SURGICAL DRAPES, MODIFICATION
    K931875 AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USE
    K931874 RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE
    K931145 NON-STERILE ISOLATION GOWN
    K932035 NON-LINTING DELIVERY BLANKET
    K925815 REUSABLE LIQUIDPROOF BOOTIE
    K921049 SURGICAL DRAPE
    K920405 STERILE SURGEON'S GOWN
    Search all 12 clearances from Amsco Sterile Recoveries, Inc. →