Ultrafera Wound Dressing
FDA 510(k) K964614 · American White Cross, Inc.
510(k) numberK964614
Submission
- Device name
- Ultrafera Wound Dressing
- Applicant
- American White Cross, Inc.
Dayville, CT, US - Received
- November 18, 1996
- Decision date
- February 6, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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|---|---|---|---|
| K241916 | TearRepair Liquid Skin ProtectantKMF · Traditional | Optmed, Inc. | 09/27/2024SE |
| 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 |
|---|---|---|
| K962400 | Air Max External Nasal Dilator StripLWF · Traditional | 09/09/1996SE |
| K894802 | Awc Butterfly Wound ClosuresFPX · Traditional | 01/31/1990SE |
| K854809 | White Cross Sterile Pad 4IN. X 4IN. · Traditional | 01/13/1986SE |
| K853558 | Dosimetric Release/Radiation Steriliz. Absorb Gauz · Traditional | 09/05/1985SE |
| K853334 | Non-Adhera Adhesive Pad 3X4NAD · Traditional | 08/21/1985SE |
| K852412 | Non-Adherent PadEFQ · Traditional | 07/29/1985SE |
| K852408 | Extra Large Adhesive StripsKGX · Traditional | 07/29/1985SE |
| K852462 | Tricot Adhesive BandageKGX · Traditional | 07/26/1985SE |
| K850595 | 3 X 4 Non-Adherent Pad · Traditional | 03/11/1985SE |
Questions and answers
When was Ultrafera Wound Dressing cleared by the FDA?
Ultrafera Wound Dressing (K964614) received a 510(k) decision of Substantially Equivalent on February 6, 1997, 80 days after the submission was received.
What is the product code of K964614?
The FDA product code is KMF – Bandage, Liquid, a Class I (low risk) device regulated under 21 CFR 880.5090.