Hydro-M(Tm) Wound Gel
FDA 510(k) K940814 · Kingston Technologies, Inc.
510(k) numberK940814
Submission
- Device name
- Hydro-M(Tm) Wound Gel
- Applicant
- Kingston Technologies, Inc.
Dayton, NJ, US - Received
- February 22, 1994
- Decision date
- May 12, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- Device class
- Unclassified
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| K024367 | Sinclair Wound and Skin EmulsionMGQ · Traditional | Sinclair Pharmaceuticals, Ltd. | 07/28/2003SE |
| K024054 | Xylos Xcell Antimicrobial DressingMGQ · Traditional | Xylos Corporation | 03/07/2003SE |
| K022584 | Cardiotech Antibotic Hydrogel Wound DressingMGQ · Traditional | Cardiotech Intl. | 12/30/2002SE |
More from Cardiotech Intl.
| 510(k) | Device | Decision |
|---|---|---|
| K935232 | Hydrotorque Guide WireDQX · Traditional | 07/20/1994SE |
| K940738 | Kti Hy-Q(Tm) Wound DressingKMF · Traditional | 05/06/1994SN |
| K925660 | Kti Transparent Wound DressingMGP · Traditional | 04/20/1993SE |
| K921502 | Hysorb Wound DressingKMF · Traditional | 09/29/1992SE |
| K882157 | Panamex(Tm) Ureteral StentFAD · Traditional | 08/02/1988SE |
Questions and answers
When was Hydro-M(Tm) Wound Gel cleared by the FDA?
Hydro-M(Tm) Wound Gel (K940814) received a 510(k) decision of Substantially Equivalent on May 12, 1994, 79 days after the submission was received.
What is the product code of K940814?
The FDA product code is MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, a Unclassified device.