BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HYPOCYN Antimicrobial Dermal Spray

    Reg #: 1000121375 · FEI: 1000121375 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SUMMERS LABORATORIES INC.
    Registration Number
    1000121375
    FEI Number
    1000121375
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    103 GP Clement Drive
    City
    Collegeville
    State
    PA
    ZIP
    19426
    Country
    US

    Regulatory Submissions

    510(k) Number
    K113693

    Owner / Operator

    Firm Name
    Summers Laboratories Inc.
    Operator Number
    10090292
    Address
    103 GP Clement Drive
    City
    Collegeville
    State
    PA
    Postal Code
    19426
    Country
    US

    Products

    Device Name Product Code
    Dressing, Wound, Drug FRO

    Proprietary Names

    HYPOCYN Antimicrobial Dermal Spray HYPOCYN Antipruritic Gel Spray

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198