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

    BEST STRAP RESTRAINT

    K Number: K963371 · Decision Nov 7, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    133
    Applicant Total
    8
    Review Days
    72

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    Basic Information

    Device Name
    BEST STRAP RESTRAINT
    K Number
    K963371
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6760
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Morrison Medical Products
    Date Received
    August 27, 1996
    Decision Date
    November 7, 1996
    Product Code
    FMQ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FMQ Restraint, Protective

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    Other Clearances by Morrison Medical Products

    K Number Device Name
    K963370 CINCH STRAP WITH BUCKLE
    K963374 TORSO/WAIST RESTRAINT
    K963387 DELUXE LIMB RESTRAINT WITH DOUBLE D-RING AND STRAP DELUXE LIMB RESTRAINT WITH STRAP
    K963416 ANKLE RESTRAINT SYSTEM
    K963399 MORRISON MEDICAL STRETCHER/COT AND BACKBOARD RESTRAINTS
    K963494 MORRISON MEDICAL DISPOSABLE RESTRAINT STRAP
    K963419 MORRISON MEDICAL WRIST RESTRAINT