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

    SALMAN SINUS BUTTON

    K Number: K922902 · Decision May 18, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    18
    Applicant Total
    33
    Review Days
    336

    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
    SALMAN SINUS BUTTON
    K Number
    K922902
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Boston Medical Products, Inc.
    Date Received
    June 16, 1992
    Decision Date
    May 18, 1993
    Product Code
    KAM
    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
    KAM Cannula, Sinus

    Similar 510(k) Clearances

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

    RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    RELIEVA STRATUS MICROFLOW SPACER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SINUS SPACER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by Boston Medical Products, Inc.

    K Number Device Name
    K091135 RUTTER SUPRA STOMAL STENTS
    K972317 MONTGOMERY THYROPLASTY IMPLANT SYSTEM
    K972459 RHINOCELL NASAL PACKINGS
    K972096 BIVALVE NASAL SPLINT
    K972078 POST-STOP EPISTAXIS CATHETER
    K972092 NASAL AIRWAY SPLINT
    K972151 DOYLE COMBO NASAL AIRWAY SPLINT
    K972082 CUSTOM NASAL SPLINT
    K972060 NASAL SEPTAL BUTTON
    K972076 EPI-MAX EPISTAXIS CATHETER
    Search all 33 clearances from Boston Medical Products, Inc. →