Dermagran Wet Dressing (Zinc-Saline)
FDA 510(k) K954742 · Derma Sciences, Inc.
510(k) numberK954742
Submission
- Device name
- Dermagran Wet Dressing (Zinc-Saline)
- Applicant
- Derma Sciences, Inc.
Old Forge, PA, US - Received
- October 16, 1995
- Decision date
- November 2, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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More from Solventum Germany GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K150985 | Medihoney Wound GelFRO · Traditional | 11/19/2015SE |
| K133279 | Medihoney Wound DressingsFRO · Traditional | 06/25/2015SE |
| K110546 | Medihoney Hydrogel Sheet Dressings with Active Leptospermum HoneyFRO · Traditional | 07/27/2011SE |
| K101793 | Medihoney Gel Dressing with Active Manuka HoneyFRO · Traditional | 02/22/2011SE |
| K081584 | Derma Sciences OTC Medihoney Dressings with Active Manuka HoneyFRO · Traditional | 06/19/2008SE |
| K080315 | Derma Sciences Medihoney Dressings with Active Manuka HoneyFRO · Traditional | 04/23/2008SE |
| K072956 | Medihoney Primary Dressings with Active Manuka HoneyFRO · Traditional | 11/07/2007SE |
| K970660 | Dermagran Wound Management SystemKMF · Traditional | 08/12/1997SE |
| K963603 | Dermagran Hydrophilic OintmentKMF · Traditional | 11/27/1996SN |
| K954743 | Dermagran Wound Dressing Cleaner W/ZincFRO · Traditional | 11/02/1995SE |
Questions and answers
When was Dermagran Wet Dressing (Zinc-Saline) cleared by the FDA?
Dermagran Wet Dressing (Zinc-Saline) (K954742) received a 510(k) decision of Substantially Equivalent on November 2, 1995, 17 days after the submission was received.
What is the product code of K954742?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.