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

    SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL

    K Number: K102403 · Decision Mar 3, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    502
    Registration Numbers
    502
    Same Product Code
    106
    Applicant Total
    4
    Review Days
    191

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    Basic Information

    Device Name
    SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL
    K Number
    K102403
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4020
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sam Medical Products
    Date Received
    August 24, 2010
    Decision Date
    March 3, 2011
    Product Code
    NAD
    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
    NAD Dressing, Wound, Occlusive

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    Other Clearances by Sam Medical Products

    K Number Device Name
    K133121 CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITO-SAM ACTIVE, 3INX6FT
    K131561 SAM JUNCTIONAL TOURNIQUET
    K123694 SAM JUNCTIONAL TOURNIQUET