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510(k) Data Aggregation

    K Number
    K190129
    Device Name
    AC5 Topical Gel
    Manufacturer
    Arch Therapeutics, Inc.
    Date Cleared
    2020-03-11

    (408 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Arch Therapeutics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Under the supervision of a health care professional, AC5 Topical dressing used for the management of partial and full- thickness wounds, such as pressure sores, leg ulcers, and surgical wounds.
    Device Description
    AC5 Topical Gel is configured as a package containing one vial of synthetic self-assembling peptide, one vial of diluent (Sterile Water for Injection, USP), one syringe, one needle, two blunt fill needle applicators and two Alcohol Prep pads. AC5 is biocompatible. The diluent (Sterile Water for Injection, USP) is sterile and non-pyrogenic. AC5 is to be prepared by reconstitution of the lyophilized peptide in Sterile Water for Injection, USP. The reconstituted peptide solution is acidic (pH 2.3 ± 0.7).
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    K Number
    K182681
    Device Name
    AC5 Topical Gel
    Manufacturer
    Arch Therapeutics, Inc.
    Date Cleared
    2018-12-14

    (79 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Arch Therapeutics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Under the supervision of a health care professional, AC5 Topical dressing used for the management of partial and full-thickness wounds, such as pressure sores, diabetic ulcers, and surgical wounds.
    Device Description
    AC5 Topical Gel is configured as a kit containing one vial of synthetic self-assembling peptide, one vial of diluent (Sterile Water for Injection, USP), one syringe, one needle, two blunt fill needle applicators and two Alcohol Prep pads. AC5 is biocompatible. The diluent (Sterile Water for Injection, USP) is sterile and non-pyrogenic. AC5 is to be prepared by reconstitution of the lyophilized peptide in Sterile Water for Injection, USP. The reconstituted peptide solution is acidic (pH 2.3 ± 0.7).
    Ask a Question

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