Jelonet Paraffin Gauze Dressings
FDA 510(k) K791573 · Acme United Corp.
510(k) numberK791573
Submission
- Device name
- Jelonet Paraffin Gauze Dressings
- Applicant
- Acme United Corp.
Mchenry, IL, US - Received
- August 10, 1979
- Decision date
- September 4, 1979
- Decision
- Substantially Equivalent (SESE)
- 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 |
| K864084 | Lyofoam C Odor-Absorbing DressingFRO · Traditional | 11/21/1986SN |
| 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 |
Questions and answers
When was Jelonet Paraffin Gauze Dressings cleared by the FDA?
Jelonet Paraffin Gauze Dressings (K791573) received a 510(k) decision of Substantially Equivalent on September 4, 1979, 25 days after the submission was received.
What is the product code of K791573?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.