BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Panpac Disposable Pessary Fitting Set

    K Number: K153422 · Decision Jul 14, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    40
    Applicant Total
    12
    Review Days
    232

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    Basic Information

    Device Name
    Panpac Disposable Pessary Fitting Set
    K Number
    K153422
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.3575
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Panpac Medical Corporation
    Date Received
    November 25, 2015
    Decision Date
    July 14, 2016
    Product Code
    HHW
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HHW Pessary, Vaginal

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    Other Clearances by Panpac Medical Corporation

    K Number Device Name
    K173351 Panpac Flexi Shelf Pessary
    K161106 PANPAC DISPOSABLE VACUUM CURETTES
    K132670 PANPAC INFLATABLE DOCUT PESSARY
    K130087 PANPAC WORD/BARTHOLIN CATHETER
    K130273 PANPAC VAGINAL DILATORS
    K102898 BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE
    K092982 THE PANPAC SUCTION CURETTE
    K092981 PANPAC VAGINAL PESSARY
    K092983 PANPAC HSG CATHETER SET
    K092984 PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0
    Search all 12 clearances from Panpac Medical Corporation →