Primed Prime-Plus Cotton Gauze Sponges
FDA 510(k) K971075 · Primeline Medical Products, Inc.
510(k) numberK971075
Submission
- Device name
- Primed Prime-Plus Cotton Gauze Sponges
- Applicant
- Primeline Medical Products, Inc.
Alberta, CA - Received
- March 24, 1997
- Decision date
- June 22, 1997
- 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 |
| 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 |
|---|---|---|
| K023266 | Primagard Surgical GownsFYA · Traditional | 11/08/2002SE |
| K023117 | Primagard Surgical GownsKKX · Traditional | 11/08/2002SE |
| K022868 | Primagard Surgical Equipment DrapesKKX · Traditional | 11/08/2002SE |
| K021864 | Primagard Nonsterile Femoral Angiography Drapes (Models PM1-0136, PM1-0119, PM1-0142)KKX · Traditional | 09/23/2002SE |
| K021076 | Primagard Yellow Surgical Mask, Pleated, Tie-On, PM4-307; Primagard Yellow Surgical…FXX · Special | 04/16/2002SE |
| K011789 | Procedure Masks: PM4-301 and PM4-304FXX · Special | 06/22/2001SE |
| K001951 | Primed Pleated Tie-Back, Procedure Mask PM4-305, Primed Pleated Ear-Loop, Procedure Mask…FXX · Traditional | 09/08/2000SE |
| K971076 | Primed Shoe Covers, Primed Head CoversFXP · Traditional | 01/13/1998SE |
Questions and answers
When was Primed Prime-Plus Cotton Gauze Sponges cleared by the FDA?
Primed Prime-Plus Cotton Gauze Sponges (K971075) received a 510(k) decision of Substantially Equivalent on June 22, 1997, 90 days after the submission was received.
What is the product code of K971075?
The FDA product code is EFQ – Gauze/Sponge, Internal, a Unclassified device.