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

    FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL)

    K Number: K872088 · Decision Aug 14, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    28
    Applicant Total
    16
    Review Days
    74

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    Basic Information

    Device Name
    FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL)
    K Number
    K872088
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5250
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Irvine Scientific
    Date Received
    June 1, 1987
    Decision Date
    August 14, 1987
    Product Code
    HDR
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HDR Cap, Cervical

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    K914541 SPERM MAINTENANCE MEDIUM WITH GLYCEROL
    K900316 MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES
    K894405 HTF WITH ALBUMIN (CATALOG NO. 9994)
    K894432 MODIFIED HAM'S F-10 W/ALBUMIN
    K874668 SPERM WASHING MEDIUM #9983 & MODIFIED #9984
    K872203 CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER)
    K872102 SPERM WASHING MEDIUM #9932
    K871577 HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPES
    K861188 SPERM CAPACITATION MEDIUM
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