Kendall Curasorb ZN + MG Alginate Wound Dressing
FDA 510(k) K973509 · Kendall Healthcare Products Co. Div.Of Tyco Health
510(k) numberK973509
Submission
- Device name
- Kendall Curasorb ZN + MG Alginate Wound Dressing
- Applicant
- Kendall Healthcare Products Co. Div.Of Tyco Health
Mansfield, MA, US - Received
- September 16, 1997
- Decision date
- December 4, 1997
- 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 |
|---|---|---|
| K973763 | Kendall Curity Iodoform Packing StripEFQ · Traditional | 12/31/1997SE |
| K973511 | Kendall Curity Petrolatum GauzeFRO · Traditional | 12/16/1997SN |
| K973507 | Kendall Xeroform Petrolatum Dressing (6311,6312,6313,6314,6315,6316,6317)FRO · Traditional | 12/15/1997SN |
| K973619 | Kendall Curity Non-Adhering DressingKMF · Traditional | 12/10/1997SN |
| K973546 | Kendall Fast-Cath Pre Lubricated Urethral CatheterEZD · Traditional | 11/07/1997SE |
| K970266 | Kendall Hydrophilic Powder Wound DressingKGN · Traditional | 04/23/1997SN |
| K963446 | Kendall Dual Lumen CatheterMPB · Traditional | 03/18/1997SE |
| K964899 | Kendall Curity Ureteral CatheterEYB · Traditional | 02/07/1997SE |
| K964519 | Curity Thoracentesis TrayGCX · Traditional | 12/20/1996SE |
| K961977 | Kendall Sher-I-Bronch Endobrochial TubeCBI · Traditional | 07/31/1996SE |
Questions and answers
When was Kendall Curasorb ZN + MG Alginate Wound Dressing cleared by the FDA?
Kendall Curasorb ZN + MG Alginate Wound Dressing (K973509) received a 510(k) decision of Substantially Equivalent for Some Indications on December 4, 1997, 79 days after the submission was received.
What is the product code of K973509?
The FDA product code is KMF – Bandage, Liquid, a Class I (low risk) device regulated under 21 CFR 880.5090.