Protec Gauze Sponge

FDA 510(k) K955321 · Derivados DE Gasa, S.A. DE C.V.

Substantially Equivalent

510(k) numberK955321

Submission

Device name
Protec Gauze Sponge
Applicant
Derivados DE Gasa, S.A. DE C.V.
Palm Harobor, FL, US
Received
November 20, 1995
Decision date
December 19, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EFQ – Gauze/Sponge, Internal
Device class
Unclassified

Other 510(k)s with product code EFQ

510(k)DeviceApplicantDecision
K991757Non-Absorbable Gauze for External Use, Sterile and Non SterileEFQ · Traditional Furlong Industries08/12/1999SE
K991215Symtex Gauze Pads (1'S) and Symtex Gauze Sponges Sterile 2'S and Sterile 10'SEFQ · Traditional Symtex Healthcare Corp.06/11/1999SE
K990974Vitop DressingEFQ · Traditional Wonder & Bioenergy Hi-Tech America, Inc.06/09/1999SE
K990584Gauze Sponges: Laparotomy Sponge, X-Ray DetectableEFQ · Traditional Broadline Medical Industries04/23/1999SE
K984187Crosstex Non-Woven SpongesEFQ · Traditional Crosstex Intl.02/18/1999SE
K983016Gauze, Sponges, Cat # 11-003EFQ · Traditional Vitalcare Group, Inc.02/12/1999SE
K983348Dynarex Tracheostomy SpongeEFQ · Traditional Dynarex Corp.12/11/1998SE
K983450Starryshine Gauze SpongeEFQ · Traditional T.C. Dental Products, Inc.11/12/1998SE
K982648Joan IIEFQ · Traditional Celanese Acetate Co.09/30/1998SE
K980791Dumex Pak-Its Woven Ribbon PackingEFQ · Traditional Dumex Medical Surgical Products, Ltd.04/29/1998SE

More from Dumex Medical Surgical Products, Ltd.

510(k)DeviceDecision
K955322Protec X-Ray Detectable Gauze SpongeGDY · Traditional 12/19/1995SE

Questions and answers

When was Protec Gauze Sponge cleared by the FDA?

Protec Gauze Sponge (K955321) received a 510(k) decision of Substantially Equivalent on December 19, 1995, 29 days after the submission was received.

What is the product code of K955321?

The FDA product code is EFQ – Gauze/Sponge, Internal, a Unclassified device.