BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    ADHEROL SEPP APPLICATOR

    K Number: K952007 · Decision Jun 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    13
    Review Days
    41

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ADHEROL SEPP APPLICATOR
    K Number
    K952007
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medi-Flex Hospital Products, Inc.
    Date Received
    April 28, 1995
    Decision Date
    June 8, 1995
    Product Code
    FRO
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FRO Dressing, Wound, Drug

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FRO), ordered by most recent decision date.

    Bonvadis®

    FDA 510(k)
    FDA Unclassified ·Unknown

    StatSeal Disc

    FDA 510(k)
    FDA Unclassified ·Unknown

    IWD-Gel™

    FDA 510(k)
    FDA Unclassified ·Unknown

    MiraChlor Antimicrobial Wound Solution

    FDA 510(k)
    FDA Unclassified ·Unknown

    Promogran Prisma™ Collagen Matrix with ORC and Silver

    FDA 510(k)
    FDA Unclassified ·Unknown

    LUOFUCON® Antimicrobial Wound Gel

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Medi-Flex Hospital Products, Inc.

    K Number Device Name
    K970441 K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH
    K962740 DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/260641
    K952201 PORT-A-CATH ACCESS KIT
    K952416 TRACHEOSTOMY CARE KIT
    K952256 PICC LINE KIT
    K934790 SEPP ADHESIVE REMOVER
    K920399 COMPOUND BENZOIN TINCTURE USP FREPP
    K923516 COMPOUND BENZOIN TINCTURE USP SEPP
    K930196 CEPTI-SEAL I.V. PREP KIT
    K921347 CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER
    Search all 13 clearances from Medi-Flex Hospital Products, Inc. →