LogoFDA 510(k) Search
K Number
K973462
Device Name
SOFTFORM FACIAL IMPLANT
Manufacturer
TISSUE TECHNOLOGIES, INC.
Date Cleared
1997-11-24

(73 days)

Product Code
FTL
Regulation Number
878.3300
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For Plastic and Reconstructive Surgery*
Prescription Use (Per 21 CFR 801.109)

  • This product is available by prescription only.
Device Description

SoftForm™ Implant

AI/ML Overview

I apologize, but the provided text only contains a letter from the FDA regarding a 510(k) premarket notification for a device called "SoftForm™ Implant." It does not include acceptance criteria, study details, or performance data for the device. The letter simply states that the FDA has determined the device to be substantially equivalent to previously marketed devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.