Alldress Multi Layered Wound Dressing
FDA 510(k) K910857 · Scott Health Care
510(k) numberK910857
Submission
- Device name
- Alldress Multi Layered Wound Dressing
- Applicant
- Scott Health Care
Philadelphia, PA, US - Received
- February 28, 1991
- Decision date
- April 12, 1991
- 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 |
|---|---|---|
| K954275 | Mepore Plus (9X15CM)KMF · Traditional | 12/27/1995SE |
| K954274 | Mepore (6X7)KMF · Traditional | 12/19/1995SE |
| K945206 | Alldress Multi Layered Wound DressingKMF · Traditional | 01/12/1995SE |
| K932743 | Mefix(R) Adhesive Fabric for Dressing FixationKGX · Traditional | 09/10/1993SE |
| K905439 | Hypergel Protective Wound GelKMF · Traditional | 05/29/1991SE |
| K905438 | Normlgel Protective Wound GelFRO · Traditional | 04/01/1991SE |
| K900421 | Promise Absorbent Protective PadHHD · Traditional | 06/06/1990SE |
| K897142 | Mesalt Sterile DressingFRO · Traditional | 03/27/1990SE |
Questions and answers
When was Alldress Multi Layered Wound Dressing cleared by the FDA?
Alldress Multi Layered Wound Dressing (K910857) received a 510(k) decision of Substantially Equivalent on April 12, 1991, 43 days after the submission was received.
What is the product code of K910857?
The FDA product code is NAB – Gauze / Sponge,Nonresorbable For External Use, a Class I (low risk) device regulated under 21 CFR 878.4014.