MAMMARY SIZER, MAMMARY PROTHESIS SIZER

• K Number: K984106
• Device Name: MAMMARY SIZER, MAMMARY PROTHESIS SIZER
• Manufacturer: SPECIALTY SURGICAL PRODUCTS, INC.
• Date Cleared: 1999-02-12 ( 87 days)
• Product Code: MRD
• Regulation Number: N/A
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

The mammary sizer is designed for single use, temporary intraoperative placement in a surgically created pocket. The sizer is used to evaluate the appropriate mammary prosthesis volume for each patient prior to implantation of a mammary prosthesis.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for a device called "Mammary Sizer." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth details. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

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

Regulation Number and Section

N/A