Gauze, Sponges, Cat # 11-003
FDA 510(k) K983016 · Vitalcare Group, Inc.
510(k) numberK983016
Submission
- Device name
- Gauze, Sponges, Cat # 11-003
- Applicant
- Vitalcare Group, Inc.
Miami, FL, US - Received
- August 28, 1998
- Decision date
- February 12, 1999
- 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 |
| 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 |
| K974316 | Hydrofera Femoral WickEFQ · Traditional | Hydrofera, LLC | 02/13/1998SE |
More from Hydrofera, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K060109 | Omi Retractable Safety SyringeMEG · Traditional | 05/05/2006SE |
| K050906 | Vitalcare I.V. Administration SetFPA · Traditional | 08/23/2005SE |
| K040916 | Vitalcare Powder Free Synthetic Vinyl Examination GloveLYZ · Traditional | 05/04/2005SE |
| K031748 | Vitalcare Sterilewater and 0.9% Sodium Chloride Pre-Filled 10CC/30CC SyringesEZL · Traditional | 08/27/2003SE |
| K992289 | Vinyl Powdered Exam Glove / Cat.# 15-020LYZ · Traditional | 08/04/1999SE |
| K983716 | Vitalcare Disposable Vaginal SpeculumHIB · Traditional | 12/23/1998SE |
| K982901 | Latex Patient Examination Glove, Cat. No. 1000M PowderedLYY · Traditional | 12/21/1998SE |
Questions and answers
When was Gauze, Sponges, Cat # 11-003 cleared by the FDA?
Gauze, Sponges, Cat # 11-003 (K983016) received a 510(k) decision of Substantially Equivalent on February 12, 1999, 168 days after the submission was received.
What is the product code of K983016?
The FDA product code is EFQ – Gauze/Sponge, Internal, a Unclassified device.