Non-Sterile Folded Gauze
FDA 510(k) K780764 · The Owenby Co.
510(k) numberK780764
Submission
- Device name
- Non-Sterile Folded Gauze
- Applicant
- The Owenby Co.
Mchenry, IL, US - Received
- May 4, 1978
- Decision date
- June 6, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- NAB – Gauze / Sponge,Nonresorbable For External Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4014
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code NAB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K946015 | Ivalon External SpongeNAB · Traditional | Ivalon | 02/27/1995SE |
| K940755 | Isolyer (4X4, 8PLY)NAB · Traditional | Isolyer Co. | 05/02/1994SE |
| K931610 | Omnisorb II, Nonwoven Sponge, Sterile and NonNAB · Traditional | Omni Mfg., Inc. | 06/24/1993SE |
| K925590 | Multi-Trauma DressingNAB · Traditional | Gam Industries, Inc. | 04/08/1993SE |
| K926072 | K-Band and K-CrepeNAB · Traditional | Parema , Ltd. | 03/19/1993SE |
| K915591 | Sterile Gauze PadsNAB · Traditional | Eagle Medical, Inc. | 01/27/1993SE |
| K924650 | Gauze SpongesNAB · Traditional | Dav-Mar Medical Products, Inc. | 01/11/1993SE |
| K923602 | Absorbent Pad -- ModificationNAB · Traditional | Winfield Laboratories, Inc. | 12/07/1992SE |
| K923115 | ClinisorbNAB · Traditional | Hermitage Hospital Products, Inc. | 11/23/1992SE |
| K923378 | Usp Type Vii Gauze SpongesNAB · Traditional | E.W.A., Ltd. | 10/06/1992SE |
More from E.W.A., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K801628 | Restraint, ProtectiveIQK · Traditional | 08/07/1980SE |
| K801627 | Cover, LimbIPM · Traditional | 07/28/1980SE |
| K801626 | Arm SlingILI · Traditional | 07/28/1980SE |
| K801532 | Stockinette, Sterile Two Ply W/Pull TabsFQM · Traditional | 07/28/1980SE |
| K801531 | Arm SlingILI · Traditional | 07/21/1980SE |
| K790210 | Stockinette, Tubular UnbleachedFQM · Traditional | 02/27/1979SE |
| K780418 | Burn Dressing PadFPY · Traditional | 04/10/1978SE |
| K770889 | Burn Dressing KitEFQ · Traditional | 07/11/1977SE |
| K761071 | P.S.M. Justa KapFYF · Traditional | 12/30/1976SE |
| K761070 | P.S.M. Surgical HoodFXY · Traditional | 12/30/1976SE |
Questions and answers
When was Non-Sterile Folded Gauze cleared by the FDA?
Non-Sterile Folded Gauze (K780764) received a 510(k) decision of Substantially Equivalent on June 6, 1978, 33 days after the submission was received.
What is the product code of K780764?
The FDA product code is NAB – Gauze / Sponge,Nonresorbable For External Use, a Class I (low risk) device regulated under 21 CFR 878.4014.