BEUDAMED
    FDA 510(k) FDA class 1 Unknown 🇺🇸 United States

    SKIN STAPLE REMOVAL TRAYS

    K Number: K943046 · Decision Jul 29, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    14
    Applicant Total
    10
    Review Days
    32

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    Basic Information

    Device Name
    SKIN STAPLE REMOVAL TRAYS
    K Number
    K943046
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Sterile Concepts, Inc.
    Date Received
    June 27, 1994
    Decision Date
    July 29, 1994
    Product Code
    MCZ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MCZ Suture Removal Kit

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    Other Clearances by Sterile Concepts, Inc.

    K Number Device Name
    K951231 ORTHOPEDIC PACKS
    K951081 OB/GYN PACKS
    K952539 RADIOLOGY PACKS
    K951478 GENERAL AND PLASTIC SURGERY PACKS
    K944139 DENTAL HYGIENE TRAY
    K943047 IV START KITS
    K943090 SUTURE REMOVAL TRAYS
    K940864 DENTIST WITH ASSISTANT PACK
    K920763 LACERATTION TRAY