N-Terface

FDA 510(k) K973538 · Winfield Laboratories, Inc.

Substantially Equivalent for Some Indications

510(k) numberK973538

Submission

Device name
N-Terface
Applicant
Winfield Laboratories, Inc.
Dallas, TX, US
Received
September 18, 1997
Decision date
December 16, 1997
Decision
Substantially Equivalent for Some Indications (SN)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
MGP – Dressing, Wound And Burn, Occlusive
Device class
Unclassified

Other 510(k)s with product code MGP

510(k)DeviceApplicantDecision
K012997Collatek FoamMGP · Traditional Biocore Medical Technologies, Inc.10/25/2001SE
K012995Collatek SheetMGP · Traditional Biocore Medical Technologies, Inc.10/25/2001SE
K001508Laserskin DressingMGP · Traditional Fidia Advanced Biopolymers Srl07/25/2001SE
K990079Fastseal Chest Wound DressingMGP · Traditional Greenfield Medical Technologies, Inc.12/23/1999SE
K991214Simplicare Transparent Wound DressingMGP · Traditional Hollister, Inc.10/14/1999SE
K992302Dermaphylyx Skin Protectors, Protect It Skin ProtectorsMGP · Traditional Dermaphylyx, Inc.09/14/1999SE
K992005Giltech Plus Transparent DressingMGP · Traditional Giltech Plus, Inc.09/03/1999SE
K990875Dermaphylyx Film Wound Dressing and Healian Film Wound DressingMGP · Traditional Dermaphylyx, Inc.05/27/1999SN
K990438Dermaflex Wound Dressing, Dermaflex Foam Wound Dressing, Healiaflex Wound Dressing…MGP · Traditional Dermaphylyx, Inc.03/25/1999SE
K984371Mepitel Non Adherent Silicone DressingMGP · Traditional Molnlycke Health Care, Inc.03/03/1999SE

More from Molnlycke Health Care, Inc.

510(k)DeviceDecision
K923602Absorbent Pad -- ModificationNAB · Traditional 12/07/1992SE
K872069Kontour Ultra Soft Sponge #SS144.50NAD · Traditional 07/14/1987SN
K820198Derma-AidNAB · Traditional 03/05/1982SE

Questions and answers

When was N-Terface cleared by the FDA?

N-Terface (K973538) received a 510(k) decision of Substantially Equivalent for Some Indications on December 16, 1997, 89 days after the submission was received.

What is the product code of K973538?

The FDA product code is MGP – Dressing, Wound And Burn, Occlusive, a Unclassified device.