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

    O.R./SURGEONS GOWN, ITEM NO. 4952

    K Number: K921152 · Decision Jul 9, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    9
    Review Days
    492

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    Basic Information

    Device Name
    O.R./SURGEONS GOWN, ITEM NO. 4952
    K Number
    K921152
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Sewing Source, Inc.
    Date Received
    March 4, 1992
    Decision Date
    July 9, 1993
    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 The Sewing Source, Inc.

    K Number Device Name
    K960045 ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE
    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