Wet Pack
FDA 510(k) K843783 · E.M. Adams
510(k) numberK843783
Submission
- Device name
- Wet Pack
- Applicant
- E.M. Adams
Medfield, MA, US - Received
- September 26, 1984
- Decision date
- December 19, 1984
- 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 |
|---|---|---|
| K971948 | Patient RestraintFMQ · Traditional | 08/06/1997SE |
| K971536 | Restraints (Vests and Jackets)FMQ · Traditional | 07/01/1997SE |
| K905173 | Splash GuardKYZ · Traditional | 04/25/1991SE |
| K910468 | Sterile Disposable Drape(S)FZI · Traditional | 03/21/1991SE |
| K873978 | Disposable Bipolar ForcepsGEN · Traditional | 11/23/1987SE |
| K850063 | Instrument Pocket · Traditional | 02/21/1985SE |
| K843724 | I.V. Start Kit & Obstetrical KitKKX · Traditional | 01/10/1985SE |
| K843782 | Dry TrayEFQ · Traditional | 12/13/1984SE |
| K843723 | Sterile Instrument Trays-VariousFSM · Traditional | 10/23/1984SE |
| K843115 | Sterile Solution BowlKDD · Traditional | 09/07/1984SE |
Questions and answers
When was Wet Pack cleared by the FDA?
Wet Pack (K843783) received a 510(k) decision of Substantially Equivalent on December 19, 1984, 84 days after the submission was received.
What is the product code of K843783?
The FDA product code is EFQ – Gauze/Sponge, Internal, a Unclassified device.