Modification to Skvekpatch
FDA 510(k) K984177 · Marine Polymer Technologies, Inc.
510(k) numberK984177
Submission
- Device name
- Modification to Skvekpatch
- Applicant
- Marine Polymer Technologies, Inc.
Danvers, MA, US - Received
- November 20, 1998
- Decision date
- December 18, 1998
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- KMF – Bandage, Liquid
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5090
- Specialty
- General Hospital
Other 510(k)s with product code KMF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K160695 | Talymed SuspensionFRO · Traditional | 12/06/2016SE |
| K132293 | Syvek Radial BandDXC · Traditional | 07/31/2014SE |
| K111524 | MP 719MTJ · Traditional | 07/22/2011SE |
| K102002 | TalymedFRO · Traditional | 07/28/2010SE |
| K082703 | MRDH BandageKMF · Traditional | 10/14/2008SE |
| K070557 | MP 719FRO · Traditional | 05/23/2007SE |
| K053300 | SyvekexcelDXC · Traditional | 03/28/2006SE |
| K002550 | RDH BandageKMF · Traditional | 12/20/2000SE |
| K972914 | Syvek PatchKGX · Traditional | 12/22/1997SE |
Questions and answers
When was Modification to Skvekpatch cleared by the FDA?
Modification to Skvekpatch (K984177) received a 510(k) decision of Substantially Equivalent for Some Indications on December 18, 1998, 28 days after the submission was received.
What is the product code of K984177?
The FDA product code is KMF – Bandage, Liquid, a Class I (low risk) device regulated under 21 CFR 880.5090.