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

    OB/GYN PACKS

    K Number: K951081 · Decision Nov 13, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    57
    Applicant Total
    10
    Review Days
    249

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    Basic Information

    Device Name
    OB/GYN PACKS
    K Number
    K951081
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sterile Concepts, Inc.
    Date Received
    March 9, 1995
    Decision Date
    November 13, 1995
    Product Code
    KNA
    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
    KNA Instrument, Manual, Specialized Obstetric-Gynecologic

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    Other Clearances by Sterile Concepts, Inc.

    K Number Device Name
    K951231 ORTHOPEDIC PACKS
    K952539 RADIOLOGY PACKS
    K951478 GENERAL AND PLASTIC SURGERY PACKS
    K944139 DENTAL HYGIENE TRAY
    K943047 IV START KITS
    K943090 SUTURE REMOVAL TRAYS
    K940864 DENTIST WITH ASSISTANT PACK
    K943046 SKIN STAPLE REMOVAL TRAYS
    K920763 LACERATTION TRAY