BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇳🇱 Netherlands

    HEMOPORE

    K Number: K141816 · Decision Oct 23, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    106
    Same Product Code
    45
    Applicant Total
    9
    Review Days
    108

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    Basic Information

    Device Name
    HEMOPORE
    K Number
    K141816
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4780
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Polyganics B.V.,
    Date Received
    July 7, 2014
    Decision Date
    October 23, 2014
    Product Code
    LYA
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LYA Splint, Intranasal Septal

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    Other Clearances by Polyganics B.V.,

    K Number Device Name
    K141423 NASOPORE-FD
    K112267 NEUROLAC(R) NERVE GUIDE
    K070715 NASOPORE EAR
    K062540 NASOPORE EAR, MODELS ND04, ND05
    K052099 NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ
    K050573 NEUROLAC NERVE GUIDE
    K042811 VIVOSORB SHEET, MODEL FS01
    K032115 NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03