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510(k) Data Aggregation

    K Number
    K991381
    Device Name
    PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA
    Date Cleared
    1999-09-24

    (156 days)

    Product Code
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    PACIFIC ANDROLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    PureCeption™ is for in vitro procedures involving sperm separation, washing and isolation.
    Device Description
    Not Found
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    K Number
    K991388
    Device Name
    ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M
    Date Cleared
    1999-09-13

    (145 days)

    Product Code
    Regulation Number
    884.6130
    Why did this record match?
    Applicant Name (Manufacturer) :

    PACIFIC ANDROLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Pacific Andrology, Inc. Microtools are a family of precision pipettes that are used for assisted reproduction procedures. They are designed, for use to denude, micromanipulate, inject, hold or transfer human gametes or embryos for assisted hatching, ICSI, or other assisted reproduction methods. ICSI micropipettes are used for the intracytoplasmic single sperm injection of oocytes. Assisted hatching micropipettes are used to effect a hole in the zona pellucida by chemical means. The Holding Micropipettes are used to hold the oocyte in position during single sperm injection with the Intracytoplasmic sperm injection (ICSI) Micropipette, to hold the embryo during the assisted hatching or during partial zona dissection procedures. Partial zona dissection micropipettes are used to facilitate assisted hatching by mechanically creating a hole in the zona pellucida. The Denuding Pipettes are used to remove cumulus cell layers from oocytes.
    Device Description
    Microtools are a family of precision pipettes.
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