Dumex Pak-Its Woven Ribbon Packing
FDA 510(k) K980791 · Dumex Medical Surgical Products, Ltd.
510(k) numberK980791
Submission
- Device name
- Dumex Pak-Its Woven Ribbon Packing
- Applicant
- Dumex Medical Surgical Products, Ltd.
Toronto, Orntario, CA - Received
- March 2, 1998
- Decision date
- April 29, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| K974316 | Hydrofera Femoral WickEFQ · Traditional | Hydrofera, LLC | 02/13/1998SE |
More from Hydrofera, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K992732 | Sterile Water & Sterile 0.9% Sodium ChlorideFOZ · Traditional | 04/20/2000SE |
| K993119 | Sterile HydrogelMGQ · Traditional | 11/23/1999SE |
| K990332 | Dumex Iodoform Packing StripFRO · Traditional | 04/14/1999SN |
| K980779 | Thalafix Natural Sea Salt DressingKMF · Traditional | 06/26/1998SN |
| K980861 | Dumex Pak-Its Cotton Gauze Packing Impregnated with HydrogelMGQ · Traditional | 05/20/1998SE |
| K980863 | Dumex Pak-Its Non-Woven Dressing Impregnated Sith Sodium Chloride (Hypertonic)KMF · Traditional | 05/11/1998SE |
| K980777 | Dumex Pak-Its-Absorbasalt Cotton Gauze PackingFRO · Traditional | 05/04/1998SE |
| K960815 | Dupad, Dupad W/Abdom. Pad, Dumex Abdom. Pad, Combo Dressing Roll/Combine Dressing RollNAD · Traditional | 04/29/1996SE |
| K950132 | Dumex Wet DressingsFRO · Traditional | 03/01/1995SN |
| K946326 | Dutex Gauze BandageEFQ · Traditional | 01/24/1995SE |
Questions and answers
When was Dumex Pak-Its Woven Ribbon Packing cleared by the FDA?
Dumex Pak-Its Woven Ribbon Packing (K980791) received a 510(k) decision of Substantially Equivalent on April 29, 1998, 58 days after the submission was received.
What is the product code of K980791?
The FDA product code is EFQ – Gauze/Sponge, Internal, a Unclassified device.