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510(k) Data Aggregation

    K Number
    K974654
    Device Name
    SILICONE BLOCKS
    Manufacturer
    SPECIALTY SURGICAL PRODUCTS, INC.
    Date Cleared
    1998-02-24

    (71 days)

    Product Code
    MIB
    Regulation Number
    874.3620
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SILICONE BLOCKS

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

    The Silicone Block is intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant to aid in the reconstruction process.

    Device Description

    Silicone Blocks

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for "Silicone Blocks." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth, or details typically found in a clinical study report.

    Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided text. This document is a regulatory communication, not a performance study report.

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