BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CLINITEX STOCKINETTE

    K Number: K973417 · Decision Dec 9, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    30
    Applicant Total
    2
    Review Days
    90

    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
    CLINITEX STOCKINETTE
    K Number
    K973417
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.5940
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Clinitex Medical Corp.
    Date Received
    September 10, 1997
    Decision Date
    December 9, 1997
    Product Code
    LGF
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LGF Component, Cast

    Similar 510(k) Clearances

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

    SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    CLINITEX CAST PADDING

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    PROTEC COTTON PADDING BANDAGE

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    QUICK-CAST IMMOBILIZER

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    CARAPACE STERILE CAST PADDING

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    ARTIFLEX(TM)

    FDA 510(k)
    FDA Class 1 ·Orthopedic
    View all

    Other Clearances by Clinitex Medical Corp.

    K Number Device Name
    K973420 CLINITEX CAST PADDING