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

    PROD. NO. 01-132 - SUTURE REMOVAL KIT

    K Number: K964827 · Decision Feb 14, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    14
    Applicant Total
    8
    Review Days
    74

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    Basic Information

    Device Name
    PROD. NO. 01-132 - SUTURE REMOVAL KIT
    K Number
    K964827
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Continental Medical Laboratories, Inc.
    Date Received
    December 2, 1996
    Decision Date
    February 14, 1997
    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 Continental Medical Laboratories, Inc.

    K Number Device Name
    K963234 STAPLE REMOVAL KIT
    K963443 PROD. NO. 02-031 - LACERATION TRAY
    K962078 TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER
    K954728 PROD NO. 01-1694 - 4X4 FOAM DRESSING
    K962073 URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY
    K952335 WOUND CARE MANAGEMENT KITS
    K905123 G-TUBE DRESSING CHANGE TRAY