Dynarex Tracheostomy Sponge
FDA 510(k) K983348 · Dynarex Corp.
510(k) numberK983348
Submission
- Device name
- Dynarex Tracheostomy Sponge
- Applicant
- Dynarex Corp.
Brewster, NY, US - Received
- September 23, 1998
- Decision date
- December 11, 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 |
| 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 |
| K974316 | Hydrofera Femoral WickEFQ · Traditional | Hydrofera, LLC | 02/13/1998SE |
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| K082863 | Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex Enteral Feeding Sets for…KNT · Traditional | 01/09/2009SE |
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Questions and answers
When was Dynarex Tracheostomy Sponge cleared by the FDA?
Dynarex Tracheostomy Sponge (K983348) received a 510(k) decision of Substantially Equivalent on December 11, 1998, 79 days after the submission was received.
What is the product code of K983348?
The FDA product code is EFQ – Gauze/Sponge, Internal, a Unclassified device.