Lyofoam C Odor-Absorbing Dressing
FDA 510(k) K864084 · Acme United Corp.
510(k) numberK864084
Submission
- Device name
- Lyofoam C Odor-Absorbing Dressing
- Applicant
- Acme United Corp.
Fairfield, CT, US - Received
- October 20, 1986
- Decision date
- November 21, 1986
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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More from Solventum Germany GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K961323 | Lyofoam Extra C Odor Absorbing Wound DressingKMF · Traditional | 06/19/1996SE |
| K961452 | Lyofoam Extra 'A' Sterile Adhesive Wound DressingKMF · Traditional | 05/31/1996SE |
| K952565 | Lyofoam ExtraKMF · Traditional | 11/14/1995SN |
| K895764 | Modified Lyofoam Wound DressingsKMF · Traditional | 09/10/1990SN |
| K871740 | Lyosheet Surgical Sheet for BurnsFPY · Traditional | 06/09/1987SE |
| K860085 | Lyofoam Wound DressingsNAD · Traditional | 06/27/1986SN |
| K860818 | One Time Enteral Feeding BagKNT · Traditional | 05/15/1986SE |
| K861015 | One Time Hyperal & Catheter Dressing Change TraysFOZ · Traditional | 04/22/1986SE |
| K842186 | Acu-Derm Transparent Wound DressingNAD · Traditional | 08/24/1984SE |
| K842064 | Acu-Derm Transparent IV DressingKMK · Traditional | 08/15/1984SE |
Questions and answers
When was Lyofoam C Odor-Absorbing Dressing cleared by the FDA?
Lyofoam C Odor-Absorbing Dressing (K864084) received a 510(k) decision of Substantially Equivalent for Some Indications on November 21, 1986, 32 days after the submission was received.
What is the product code of K864084?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.