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

    CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680

    K Number: K964336 · Decision Mar 20, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    10
    Review Days
    140

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    Basic Information

    Device Name
    CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680
    K Number
    K964336
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4350
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cryomedical Sciences, Inc.
    Date Received
    October 31, 1996
    Decision Date
    March 20, 1997
    Product Code
    GEH
    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
    GEH Unit, Cryosurgical, Accessories

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    Other Clearances by Cryomedical Sciences, Inc.

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    K980668 CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 790
    K980670 CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 722
    K973190 ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES
    K970995 CMS CRYOLITE
    K953637 CMS ACCUPROBE 550/530
    K952895 CMS URETHRAL WARMER
    K904421 CMS ONCOPROBE (TM)