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K Number
K982258
Device Name
MAMMARY SIZER
Manufacturer
SPECIALTY SURGICAL PRODUCTS, INC.
Date Cleared
1998-09-08

(74 days)

Product Code
MRD
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Specialty Surgical Products Mammary Sizer is intended to assist in evaluation of the appropriate mammary prosthesis volume for each patient prior to implantation.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA to Specialty Surgical Products, Inc. for their Mammary Sizer device. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The letter is a notification of substantial equivalence for a medical device and thus does not describe the technical details of the device's validation. It primarily focuses on regulatory aspects and the device's classification.

Therefore, I cannot provide the requested information based on the input text.

N/A