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510(k) Data Aggregation

    K Number
    K031660
    Device Name
    FERRIS POLYMEM STERILE BREAST PAD
    Manufacturer
    FERRIS MFG. CORP.
    Date Cleared
    2005-02-22

    (636 days)

    Product Code
    NTX
    Regulation Number
    880.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    FERRIS MFG. CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Over the Counter Use: To be worn inside the bra to: - Soothe tender, sore, irritated, cracked or painful nipples caused by breastfeeding . - Absorb milk leakage . - Protect the nipple from abrasion and friction damage caused by bra or clothing . - Help alleviate discomfort . - Protect clothing from milk leakage .
    Device Description
    FERRIS PolyMem® STERILE BREAST PAD
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    K Number
    K031307
    Device Name
    FERRIS POLYMEM SILVER WOUND DRESSING
    Manufacturer
    FERRIS MFG. CORP.
    Date Cleared
    2003-10-22

    (181 days)

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

    FERRIS MFG. CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the management of: Pressure Ulcers (Stages I-IV), Leg ulcers, Diabetic ulcers, Venous stasis ulcers, Donor and graft sites, Dermatologic disorders, Acute wounds, Skin tears, 1st and 2nd degree burns
    Device Description
    Not Found
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    K Number
    K002129
    Device Name
    FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN
    Manufacturer
    FERRIS MFG. CORP.
    Date Cleared
    2000-08-25

    (42 days)

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

    FERRIS MFG. CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991729
    Device Name
    FERRIS POLYOSTOMY STERILE WOUND DRESSING
    Manufacturer
    FERRIS MFG. CORP.
    Date Cleared
    1999-08-27

    (99 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    FERRIS MFG. CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ostomy Tube Sites Drainage Tube Sites Gastrointestinal Tube Sites Feeding Tube Sites
    Device Description
    FERRIS POLYOSTOMY STERILE WOUND DRESSING
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    K Number
    K990906
    Device Name
    FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER
    Manufacturer
    FERRIS MFG. CORP.
    Date Cleared
    1999-04-29

    (42 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    FERRIS MFG. CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Arterial Ulcers Pressure Ulcers (Stage III-IV) Venous Ulcers Diabetic Ulcers
    Device Description
    FERRIS ... LOLLEWIC CARLY WOUND FILLER
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    K Number
    K984539
    Device Name
    FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING
    Manufacturer
    FERRIS MFG. CORP.
    Date Cleared
    1999-03-01

    (70 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    FERRIS MFG. CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the management of Leg ulcers Venous ulcers Diabetic ulcers Arterial ulcers Abrasions Second degree burns Full and partial thickness pressure ulcers Dehisced incisions
    Device Description
    Ferris PolyMem Calcium Alginate Dressing
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    K Number
    K982306
    Device Name
    POLYTUBE
    Manufacturer
    FERRIS MFG. CORP.
    Date Cleared
    1998-09-22

    (83 days)

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

    FERRIS MFG. CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the management, including cushioning of, and absorption of fluid around: Tracheostomy tube sites drainage tube sites Gastrointestinal tube sites feeding tube sites
    Device Description
    FERRIS POLYMEM POLYTUBE TUBE SITE DRESSING
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