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

    Q4.5-5.0PB-4.5

    K Number: K951342 · Decision Apr 25, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    370
    Registration Numbers
    370
    Same Product Code
    72
    Applicant Total
    7
    Review Days
    33

    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
    Q4.5-5.0PB-4.5
    K Number
    K951342
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6890
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Central Solutions, Inc.
    Date Received
    March 23, 1995
    Decision Date
    April 25, 1995
    Product Code
    LRJ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LRJ Disinfectant, Medical Devices

    Similar 510(k) Clearances

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

    CONTROL III ELITE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PRO-PORTION CLEANER/DISINFECTANT

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MICROSTAT 2

    FDA 510(k)
    FDA Class 1 ·General Hospital

    AMERSE 2

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LOW PH PHENOLIC 256

    FDA 510(k)
    FDA Class 1 ·General Hospital
    View all

    Other Clearances by Central Solutions, Inc.

    K Number Device Name
    K983585 LOW PH PHENOLIC 256
    K955850 PRO-TECH
    K954292 Q5. 5-5.5NPB-2.5HW
    K951020 TRI-CEN GERMICIDAL DETERGENT
    K951162 PHENO-CEN GERMICIDAL DETERGENT
    K951317 PHENO-CEN SPRAY DISINFECTANT DEODORANT