Lyofoam Extra 'A' Sterile Adhesive Wound Dressing
FDA 510(k) K961452 · Acme United Corp.
510(k) numberK961452
Submission
- Device name
- Lyofoam Extra 'A' Sterile Adhesive Wound Dressing
- Applicant
- Acme United Corp.
Fairfield, CT, US - Received
- April 16, 1996
- Decision date
- May 31, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KMF – Bandage, Liquid
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5090
- Specialty
- General Hospital
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| K182733 | Rochal Bioshield Silicone FilmKMF · Traditional | Rochal Industries, LLC | 06/27/2019SE |
| K171148 | Aleo BME Liquid BandageKMF · Traditional | Aleo Bme, Inc. | 01/12/2018SE |
| K153571 | Cavilon Advanced High Endurance Skin ProtectantKMF · Traditional | 3M Healthcare | 08/23/2016SE |
| K160684 | Atteris No-Sting Skin ProtectantKMF · Traditional | Rochal Industries, LLC | 07/26/2016SE |
| K131384 | Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage, Liquid BandageKMF · Traditional | Kericure, Inc. | 08/07/2014SE |
| K133443 | Marathon No Sting Liquid Skin ProtectantKMF · Traditional | Advanced Medical Solutions (Plymouth), Ltd. | 07/10/2014SE |
| K120059 | Liquid BandageKMF · Traditional | Chesson Laboratory Associates, Inc. | 05/17/2012SE |
| K092712 | Skin Barrier FilmKMF · Traditional | Lodestar Products, Inc. | 02/23/2010SE |
| K083087 | EcocelKMF · Traditional | Polichem S.A | 08/07/2009SE |
More from Polichem S.A
| 510(k) | Device | Decision |
|---|---|---|
| K961323 | Lyofoam Extra C Odor Absorbing Wound DressingKMF · Traditional | 06/19/1996SE |
| 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 |
| K842064 | Acu-Derm Transparent IV DressingKMK · Traditional | 08/15/1984SE |
Questions and answers
When was Lyofoam Extra 'A' Sterile Adhesive Wound Dressing cleared by the FDA?
Lyofoam Extra 'A' Sterile Adhesive Wound Dressing (K961452) received a 510(k) decision of Substantially Equivalent on May 31, 1996, 45 days after the submission was received.
What is the product code of K961452?
The FDA product code is KMF – Bandage, Liquid, a Class I (low risk) device regulated under 21 CFR 880.5090.