Sterigauze Wet Dressing
FDA 510(k) K952420 · Acacia Laboratories, Inc.
510(k) numberK952420
Submission
- Device name
- Sterigauze Wet Dressing
- Applicant
- Acacia Laboratories, Inc.
Santa Ana, CA, US - Received
- May 23, 1995
- Decision date
- July 12, 1995
- 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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|---|---|---|---|
| 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 |
|---|---|---|
| K952419 | Sterigauze Gel DressingMGQ · Traditional | 07/26/1995SE |
| K951861 | Stericare Wound Care GelMGQ · Traditional | 07/11/1995SE |
| K952414 | Prefilled Syringe for Inflation of Foley CatheterKNY · Traditional | 06/23/1995SE |
| K951914 | Hydracare Absorbent Wound DressingKMF · Traditional | 05/15/1995SN |
| K950344 | Horizon Foley Catheterization Tray Without CatheterFCM · Traditional | 03/24/1995SEKD |
| K913408 | Sterile Plastic DrapeKKX · Traditional | 03/12/1992SE |
| K901761 | Sterile Suction Tubing SetBYY · Traditional | 05/07/1990SE |
| K892856 | Newmark(Tm) Coronary Artery Bypass Graft MarkersKRI · Traditional | 11/08/1989SE |
| K892804 | Newchill(Tm) Cardiac InsulatorDWS · Traditional | 07/14/1989SE |
| K884055 | Surgi-Tag(Tm) Sterile Label SetsLYV · Traditional | 10/13/1988SE |
Questions and answers
When was Sterigauze Wet Dressing cleared by the FDA?
Sterigauze Wet Dressing (K952420) received a 510(k) decision of Substantially Equivalent on July 12, 1995, 50 days after the submission was received.
What is the product code of K952420?
The FDA product code is KMF – Bandage, Liquid, a Class I (low risk) device regulated under 21 CFR 880.5090.