BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    HOSPITAL KIT SV 105

    K Number: K922133 · Decision Jun 7, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    109
    Applicant Total
    7
    Review Days
    397

    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
    HOSPITAL KIT SV 105
    K Number
    K922133
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Savoy Medical Supply Co., Inc.
    Date Received
    May 6, 1992
    Decision Date
    June 7, 1993
    Product Code
    LRO
    Advisory Committee
    General, Plastic Surgery
    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
    LRO General Surgery Tray

    Similar 510(k) Clearances

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

    Medline General Surgery Tray

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Medline Cardiovascular Procedure Kit

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SURGICAL DRAPE KIT - D.I.R.R.A. SRL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AMSINO TRACHEOSTOMY CARE TRAY

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Savoy Medical Supply Co., Inc.

    K Number Device Name
    K922130 HOSPITAL KIT DK 117
    K922127 HOSPITAL KIT GP 103
    K923281 SV 100200 - SINGLE USE ONLY - STERILE HOSPITAL KIT
    K922128 HOSPITAL KIT EP 104
    K922126 HOSPITAL KIT ENT 1125
    K923283 SUP 5415 SINGLE USE ONLY STERILE HOSPITAL KIT