BEUDAMED
    FDA Registration Active 🇫🇷 France

    OPTIME R

    Reg #: 3004060107 · FEI: 3004060107 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    PETERS SURGICAL
    Registration Number
    3004060107
    FEI Number
    3004060107
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Immeuble Aurelium, 1 cours de l'ile Seguin
    City
    BOULOGNE-BILLANCOURT Hauts-de-Seine
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K233265

    Owner / Operator

    Firm Name
    PETERS SURGICAL
    Operator Number
    9009304
    Address
    Immeuble Aurelium 1 cours de l'ile seguin
    City
    BOULOGNE BILLANCOURT
    State
    Hauts-de-Seine
    Postal Code
    92100
    Country
    FR
    Correspondent
    Marie COMPAGNON-RIOBE

    US Agent

    Business Name
    VITALITEC INT'L., INC.
    Contact Name
    Ellen Henke-Knupp
    Address
    10 Cordage Park Cir # 100
    City
    Plymouth
    State
    MA
    ZIP
    02360
    Country
    US
    Email
    [email protected]
    Phone
    508 7476033

    Products

    Device Name Product Code
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM

    Proprietary Names

    OPTIME R

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility