Hydrasorb Sterile Dressing

FDA 510(k) K973260 · Avitar, Inc.

Substantially Equivalent

510(k) numberK973260

Submission

Device name
Hydrasorb Sterile Dressing
Applicant
Avitar, Inc.
Canton, MA, US
Received
August 29, 1997
Decision date
October 21, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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
K925841Hydrasorb Joyce SpongeNAC · Traditional 05/12/1993SE
K897102Hydrasorb(Tm)JOH · Traditional 04/23/1990SE
K897156Hydrasorb(Tm)NAD · Traditional 02/21/1990SE

Questions and answers

When was Hydrasorb Sterile Dressing cleared by the FDA?

Hydrasorb Sterile Dressing (K973260) received a 510(k) decision of Substantially Equivalent on October 21, 1997, 53 days after the submission was received.

What is the product code of K973260?

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