Eye Pad
FDA 510(k) K912955 · Cal West Trading Co.
510(k) numberK912955
Submission
- Device name
- Eye Pad
- Applicant
- Cal West Trading Co.
Santa Fe Springs, CA, US - Received
- July 2, 1991
- Decision date
- September 10, 1991
- 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 |
|---|---|---|
| K950392 | 4-O2 Plus (CPR) Mouth Barrier, Catalog No. 08050CBP · Traditional | 02/21/1995SE |
| K933756 | Magnashield CPR Mouth BarrierCBP · Traditional | 01/05/1994SE |
| K920269 | Ez Gauze SpongeNAB · Traditional | 04/22/1992SE |
| K914842 | Gauze Bandage RollNAB · Traditional | 12/04/1991SE |
| K912952 | Bandage CompressNAB · Traditional | 10/04/1991SE |
| K912950 | Compress DressingNAB · Traditional | 10/04/1991SE |
| K912953 | Gauze CompressNAB · Traditional | 09/30/1991SE |
| K912954 | Stretch Gauze BandageNAB · Traditional | 09/10/1991SE |
| K912951 | 12-PLY Gauze PadNAB · Traditional | 09/10/1991SE |
| K912949 | Triangular BANDAGE,40NAB · Traditional | 09/06/1991SE |
Questions and answers
When was Eye Pad cleared by the FDA?
Eye Pad (K912955) received a 510(k) decision of Substantially Equivalent on September 10, 1991, 70 days after the submission was received.
What is the product code of K912955?
The FDA product code is EFQ – Gauze/Sponge, Internal, a Unclassified device.