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

    RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE

    K Number: K931874 · Decision Jun 10, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    12
    Review Days
    422

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    Basic Information

    Device Name
    RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE
    K Number
    K931874
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Amsco Sterile Recoveries, Inc.
    Date Received
    April 14, 1993
    Decision Date
    June 10, 1994
    Product Code
    FRG
    Advisory Committee
    General Hospital
    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
    FRG Wrap, Sterilization

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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
    K931145 NON-STERILE ISOLATION GOWN
    K931144 STERILE SURGEON'S GOWN, MODIFICATION
    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. →