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

    SUTURE REMOVAL TRAYS

    K Number: K943090 · Decision Aug 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    10
    Review Days
    55

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    Basic Information

    Device Name
    SUTURE REMOVAL TRAYS
    K Number
    K943090
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Sterile Concepts, Inc.
    Date Received
    June 28, 1994
    Decision Date
    August 22, 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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    K944139 DENTAL HYGIENE TRAY
    K943047 IV START KITS
    K940864 DENTIST WITH ASSISTANT PACK
    K943046 SKIN STAPLE REMOVAL TRAYS
    K920763 LACERATTION TRAY