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

    ALEXANDER BOX, BATTERY, RECHARGEABLE

    K Number: K963305 · Decision Apr 17, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    2
    Applicant Total
    39
    Review Days
    238

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    Basic Information

    Device Name
    ALEXANDER BOX, BATTERY, RECHARGEABLE
    K Number
    K963305
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Alexander Mfg. Co.
    Date Received
    August 22, 1996
    Decision Date
    April 17, 1997
    Product Code
    BWA
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BWA Unit, Electrosurgical And Coagulation, With Accessories

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    Other Clearances by Alexander Mfg. Co.

    K Number Device Name
    K982896 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9
    K981776 ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X
    K981728 ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134
    K980224 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822
    K974061 RECHARGEABLE BATTERY PART NUMBER GL825-200
    K973851 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M12/630
    K973850 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007
    K972746 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100
    K972780 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625
    K972779 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS3030-P
    Search all 39 clearances from Alexander Mfg. Co. →