Catheter Care Kit Reorder 7940&7941
FDA 510(k) K791888 · Ascep, Inc.
510(k) numberK791888
Submission
- Device name
- Catheter Care Kit Reorder 7940&7941
- Applicant
- Ascep, Inc.
Mchenry, IL, US - Received
- September 11, 1979
- Decision date
- October 17, 1979
- 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 |
|---|---|---|
| K830219 | Various Instruments & Instrument TraysFSM · Traditional | 04/12/1983SE |
| K822893 | G.E.V. Disposable ScalpelsGDX · Traditional | 10/22/1982SE |
| K810004 | Sterile Disposable Instrument TraysFSM · Traditional | 01/26/1981SE |
| K802726 | Instruments Nonsterile & SterileHAO · Traditional | 11/19/1980SE |
| K791886 | I.V. Care KitKGX · Traditional | 10/26/1979SE |
| K791885 | I.V. Start SetKGX · Traditional | 10/22/1979SE |
| K791889 | Suture Removal Tray, Reorder 7950&7951FSM · Traditional | 10/17/1979SE |
| K791887 | Central Venous Catheter Dressing TrayFSM · Traditional | 10/17/1979SE |
Questions and answers
When was Catheter Care Kit Reorder 7940&7941 cleared by the FDA?
Catheter Care Kit Reorder 7940&7941 (K791888) received a 510(k) decision of Substantially Equivalent on October 17, 1979, 36 days after the submission was received.
What is the product code of K791888?
The FDA product code is EFQ – Gauze/Sponge, Internal, a Unclassified device.