Butcher Strung Tonsil Sponge
FDA 510(k) K882529 · Ormed Mfg., Inc.
510(k) numberK882529
Submission
- Device name
- Butcher Strung Tonsil Sponge
- Applicant
- Ormed Mfg., Inc.
Buffalo, NY, US - Received
- June 21, 1988
- Decision date
- July 18, 1988
- 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 |
|---|---|---|
| K931555 | Artromot K2 CPMBXB · Traditional | 01/31/1994SE |
| K882530 | Tape Strung Tonsil SpongeEFQ · Traditional | 07/18/1988SE |
| K882528 | Cylindrical SpongeEFQ · Traditional | 07/18/1988SE |
| K882527 | Gauze SpongeEFQ · Traditional | 07/18/1988SE |
| K880911 | Blunt SpongeEFQ · Traditional | 03/17/1988SE |
| K880910 | Round Stick SpongesEFQ · Traditional | 03/17/1988SE |
| K880909 | Tracheotomy SpongesEFQ · Traditional | 03/17/1988SE |
| K880907 | Triangle SpongeEFQ · Traditional | 03/17/1988SE |
| K880854 | Strung Absorbent BallsEFQ · Traditional | 03/17/1988SE |
| K880853 | Cherry SpongeEFQ · Traditional | 03/17/1988SE |
Questions and answers
When was Butcher Strung Tonsil Sponge cleared by the FDA?
Butcher Strung Tonsil Sponge (K882529) received a 510(k) decision of Substantially Equivalent on July 18, 1988, 27 days after the submission was received.
What is the product code of K882529?
The FDA product code is EFQ – Gauze/Sponge, Internal, a Unclassified device.