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

    MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS

    K Number: K052253 · Decision Nov 2, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    122
    Applicant Total
    24
    Review Days
    76

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    Basic Information

    Device Name
    MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS
    K Number
    K052253
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gambro Renal Products
    Date Received
    August 18, 2005
    Decision Date
    November 2, 2005
    Product Code
    KPO
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

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    Other Clearances by Gambro Renal Products

    K Number Device Name
    K120333 PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY
    K072908 PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY
    K070414 GAMBRO CARTRIDGE BLOOD SETS
    K063290 GAMBRO QUICKSET BLOODLINES
    K062090 PRISMA SYSTEM R03.10A
    K060195 GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE
    K051520 GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H
    K033262 MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)
    K043342 POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR
    K042797 WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
    Search all 24 clearances from Gambro Renal Products →