Stay Fresh Skin Fold Management Textile

FDA 510(k) K121898 · Quick-Med Technologies, Inc.

Substantially Equivalent

510(k) numberK121898

Submission

Device name
Stay Fresh Skin Fold Management Textile
Applicant
Quick-Med Technologies, Inc.
North Attleboro, MA, US
Received
June 29, 2012
Decision date
May 24, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FRL – Fiber, Medical, Absorbent
Device class
Class I (low risk)
Regulation
21 CFR 880.5300
Specialty
General Hospital

Other 510(k)s with product code FRL

510(k)DeviceApplicantDecision
K110715Interdry SilverFRL · Traditional Milliken Healthcare Products, LLC11/04/2011SE
K061615Interdry Textile with SilverFRL · Traditional Milliken Chemical12/22/2006SE
K931626Carapace Sterile Cotton BallsFRL · Traditional Carapace, Inc.12/02/1993SE
K914081Ican Cotton Rayon BallsFRL · Traditional Icn Pharmaceuticals, Inc.10/09/1991SE
K811990Trach Cleaning TrayFRL · Traditional Associated Medical Products Co.07/27/1981SE
K810242Utensil & Procedure TraysFRL · Traditional American Hospital Supply Corp.04/15/1981SE
K800277Medspec Rayon BallsFRL · Traditional Medspec Corp.03/12/1980SE
K800249Surgitek Foerster Mammary BandageFRL · Traditional Medical Engineering Corp.02/19/1980SE
K800248Surgitek Foerster Face Lift BandageFRL · Traditional Medical Engineering Corp.02/19/1980SE
K792295SorbiesFRL · Traditional American Hospital Supply Corp.12/20/1979SE

Questions and answers

When was Stay Fresh Skin Fold Management Textile cleared by the FDA?

Stay Fresh Skin Fold Management Textile (K121898) received a 510(k) decision of Substantially Equivalent on May 24, 2013, 329 days after the submission was received.

What is the product code of K121898?

The FDA product code is FRL – Fiber, Medical, Absorbent, a Class I (low risk) device regulated under 21 CFR 880.5300.