Burn Dressing Kit
FDA 510(k) K770889 · The Owenby Co.
510(k) numberK770889
Submission
- Device name
- Burn Dressing Kit
- Applicant
- The Owenby Co.
Mchenry, IL, US - Received
- May 16, 1977
- Decision date
- July 11, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EFQ – Gauze/Sponge, Internal
- Device class
- Unclassified
Other 510(k)s with product code EFQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K991757 | Non-Absorbable Gauze for External Use, Sterile and Non SterileEFQ · Traditional | Furlong Industries | 08/12/1999SE |
| K991215 | Symtex Gauze Pads (1'S) and Symtex Gauze Sponges Sterile 2'S and Sterile 10'SEFQ · Traditional | Symtex Healthcare Corp. | 06/11/1999SE |
| K990974 | Vitop DressingEFQ · Traditional | Wonder & Bioenergy Hi-Tech America, Inc. | 06/09/1999SE |
| K990584 | Gauze Sponges: Laparotomy Sponge, X-Ray DetectableEFQ · Traditional | Broadline Medical Industries | 04/23/1999SE |
| K984187 | Crosstex Non-Woven SpongesEFQ · Traditional | Crosstex Intl. | 02/18/1999SE |
| K983016 | Gauze, Sponges, Cat # 11-003EFQ · Traditional | Vitalcare Group, Inc. | 02/12/1999SE |
| K983348 | Dynarex Tracheostomy SpongeEFQ · Traditional | Dynarex Corp. | 12/11/1998SE |
| K983450 | Starryshine Gauze SpongeEFQ · Traditional | T.C. Dental Products, Inc. | 11/12/1998SE |
| K982648 | Joan IIEFQ · Traditional | Celanese Acetate Co. | 09/30/1998SE |
| K980791 | Dumex Pak-Its Woven Ribbon PackingEFQ · Traditional | Dumex Medical Surgical Products, Ltd. | 04/29/1998SE |
More from Dumex Medical Surgical Products, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K801628 | Restraint, ProtectiveIQK · Traditional | 08/07/1980SE |
| K801627 | Cover, LimbIPM · Traditional | 07/28/1980SE |
| K801626 | Arm SlingILI · Traditional | 07/28/1980SE |
| K801532 | Stockinette, Sterile Two Ply W/Pull TabsFQM · Traditional | 07/28/1980SE |
| K801531 | Arm SlingILI · Traditional | 07/21/1980SE |
| K790210 | Stockinette, Tubular UnbleachedFQM · Traditional | 02/27/1979SE |
| K780764 | Non-Sterile Folded GauzeNAB · Traditional | 06/06/1978SE |
| K780418 | Burn Dressing PadFPY · Traditional | 04/10/1978SE |
| K761071 | P.S.M. Justa KapFYF · Traditional | 12/30/1976SE |
| K761070 | P.S.M. Surgical HoodFXY · Traditional | 12/30/1976SE |
Questions and answers
When was Burn Dressing Kit cleared by the FDA?
Burn Dressing Kit (K770889) received a 510(k) decision of Substantially Equivalent on July 11, 1977, 56 days after the submission was received.
What is the product code of K770889?
The FDA product code is EFQ – Gauze/Sponge, Internal, a Unclassified device.