Non-Adherent Pad
FDA 510(k) K852412 · American White Cross, Inc.
510(k) numberK852412
Submission
- Device name
- Non-Adherent Pad
- Applicant
- American White Cross, Inc.
Stamford, CT, US - Received
- June 6, 1985
- Decision date
- July 29, 1985
- 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 |
|---|---|---|
| K964614 | Ultrafera Wound DressingKMF · Traditional | 02/06/1997SE |
| K962400 | Air Max External Nasal Dilator StripLWF · Traditional | 09/09/1996SE |
| K894802 | Awc Butterfly Wound ClosuresFPX · Traditional | 01/31/1990SE |
| K854809 | White Cross Sterile Pad 4IN. X 4IN. · Traditional | 01/13/1986SE |
| K853558 | Dosimetric Release/Radiation Steriliz. Absorb Gauz · Traditional | 09/05/1985SE |
| K853334 | Non-Adhera Adhesive Pad 3X4NAD · Traditional | 08/21/1985SE |
| K852408 | Extra Large Adhesive StripsKGX · Traditional | 07/29/1985SE |
| K852462 | Tricot Adhesive BandageKGX · Traditional | 07/26/1985SE |
| K850595 | 3 X 4 Non-Adherent Pad · Traditional | 03/11/1985SE |
Questions and answers
When was Non-Adherent Pad cleared by the FDA?
Non-Adherent Pad (K852412) received a 510(k) decision of Substantially Equivalent on July 29, 1985, 53 days after the submission was received.
What is the product code of K852412?
The FDA product code is EFQ – Gauze/Sponge, Internal, a Unclassified device.