Hydracare Absorbent Wound Dressing
FDA 510(k) K951914 · Acacia Laboratories, Inc.
510(k) numberK951914
Submission
- Device name
- Hydracare Absorbent Wound Dressing
- Applicant
- Acacia Laboratories, Inc.
Santa Ana, CA, US - Received
- April 24, 1995
- Decision date
- May 15, 1995
- 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
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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 |
| K952420 | Sterigauze Wet DressingKMF · Traditional | 07/12/1995SE |
| K951861 | Stericare Wound Care GelMGQ · Traditional | 07/11/1995SE |
| K952414 | Prefilled Syringe for Inflation of Foley CatheterKNY · Traditional | 06/23/1995SE |
| 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 Hydracare Absorbent Wound Dressing cleared by the FDA?
Hydracare Absorbent Wound Dressing (K951914) received a 510(k) decision of Substantially Equivalent for Some Indications on May 15, 1995, 21 days after the submission was received.
What is the product code of K951914?
The FDA product code is KMF – Bandage, Liquid, a Class I (low risk) device regulated under 21 CFR 880.5090.