Mitrasheer Transplant Dressing

FDA 510(k) K911649 · Polymint Industrial Co. , Ltd.

Substantially Equivalent

510(k) numberK911649

Submission

Device name
Mitrasheer Transplant Dressing
Applicant
Polymint Industrial Co. , Ltd.
Wheat Ridge, CO, US
Received
April 12, 1991
Decision date
August 7, 1991
Decision
Substantially Equivalent (SESE)
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
K932457Spyrogel Wound DressingKGX · Traditional 02/09/1994SN
K931634Various KitsLRR · Traditional 11/30/1993SEKD
K921775Spyroflex Wound ClosuresFPX · Traditional 05/19/1992SE
K891644Sambord Latex Patient Examination GlovesLYY · Traditional 06/19/1989SE

Questions and answers

When was Mitrasheer Transplant Dressing cleared by the FDA?

Mitrasheer Transplant Dressing (K911649) received a 510(k) decision of Substantially Equivalent on August 7, 1991, 117 days after the submission was received.

What is the product code of K911649?

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