Chevron Tape Dissector, 9/16 X 1/4, 9/16 X 1/8
FDA 510(k) K872808 · American Silk Sutures, Inc.
510(k) numberK872808
Submission
- Device name
- Chevron Tape Dissector, 9/16 X 1/4, 9/16 X 1/8
- Applicant
- American Silk Sutures, Inc.
Lynn, MA, US - Received
- July 14, 1987
- Decision date
- August 4, 1987
- 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 |
|---|---|---|
| K922143 | American Burn SheetKME · Traditional | 08/10/1992SE |
| K904514 | Strung Telfa Non-Adherent SpongeHBA · Traditional | 03/27/1991SE |
| K902921 | Rayon Neurological SpongeHBA · Traditional | 09/18/1990SE |
| K872810 | Strung Dental RollsEFN · Traditional | 12/04/1987SE |
| K872951 | American Brain Retractor CoverGET · Traditional | 09/16/1987SE |
| K872905 | American Nasal SpongeEPP · Traditional | 09/04/1987SE |
| K872906 | Suction Tube Tip Fits Over Bussie Frazier TubeGEA · Traditional | 08/11/1987SE |
| K872809 | Gauze Cherry SpongeGDY · Traditional | 08/04/1987SE |
| K872807 | Non-Woven Tracheotomy SpongeGDY · Traditional | 08/04/1987SE |
| K872806 | Stick Sponge, Strung Tonsil Sponge Double StrungEFQ · Traditional | 08/04/1987SE |
Questions and answers
When was Chevron Tape Dissector, 9/16 X 1/4, 9/16 X 1/8 cleared by the FDA?
Chevron Tape Dissector, 9/16 X 1/4, 9/16 X 1/8 (K872808) received a 510(k) decision of Substantially Equivalent on August 4, 1987, 21 days after the submission was received.
What is the product code of K872808?
The FDA product code is EFQ – Gauze/Sponge, Internal, a Unclassified device.