LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K971317
    Device Name
    NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS
    Manufacturer
    NATIONAL HEALTHCARE MFG. CORP.
    Date Cleared
    1997-05-08

    (29 days)

    Product Code
    KDD
    Regulation Number
    878.4800
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    Orthopedic Kit or Tray

    AI/ML Overview

    I am sorry, but the provided text from the 510(k) summary (Attachment 1) does not contain information about acceptance criteria, device performance, clinical studies, sample sizes, ground truth, or expert involvement.

    The document primarily focuses on:

    • Submitter Information: Name and address of National Healthcare Manufacturing Corp. and their general manager.
    • 510(k) Summary Preparer: Information about the consultant preparing the summary.
    • Date Prepared: April 1, 1997.
    • Device Name/Classification: Identifying the device as an "Orthopedic Pack, Tray, or Kit" and noting the absence of a specific classification name.

    Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1