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

    MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX

    K Number: K020077 · Decision Jan 31, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    25
    Review Days
    22

    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
    MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX
    K Number
    K020077
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    878.4020
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Augustine Medical, Inc.
    Date Received
    January 9, 2002
    Decision Date
    January 31, 2002
    Product Code
    MSA
    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
    MSA Dressing, Wound And Burn, Occlusive, Heated

    Similar 510(k) Clearances

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

    AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX

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

    Other Clearances by Augustine Medical, Inc.

    K Number Device Name
    K021473 BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
    K001149 AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK
    K973741 BAIR HUGGER BLOOD/FLUID WARMER
    K964673 BAIR HUGGER MODEL 630 CARDIAC BLANKET
    K963293 AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX
    K963672 MODEL 90022 ROLLING STAND
    K960167 SYSTEM, THERMAL REGULATING 74-DWJ
    K954446 AUGUSTINE INTUBATION GUIDE
    K952864 BAIR HUGGER MODEL 655 BLANKET
    K950416 BAIR HUGGER MODEL 600 UNIT, BLANKETS
    Search all 25 clearances from Augustine Medical, Inc. →