Dermassist(Tm) Hydrogel Saturated Gauze Dressing
FDA 510(k) K946030 · Wilshire Medical Products
510(k) numberK946030
Submission
- Device name
- Dermassist(Tm) Hydrogel Saturated Gauze Dressing
- Applicant
- Wilshire Medical Products
Dallas, TX, US - Received
- December 9, 1994
- Decision date
- February 27, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
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More from Cardiotech Intl.
| 510(k) | Device | Decision |
|---|---|---|
| K946031 | Dermassist(Tm) Hydrogel Saturateed Non Woven DressingMGQ · Traditional | 02/27/1995SE |
| K944333 | Hydroderm Gel Wound DressingMGQ · Traditional | 11/10/1994SN |
| K941216 | Hydroderm Extra Thin Intelligent Hydrocollioid DressingKMF · Traditional | 05/20/1994SN |
| K941149 | Dermaassist Hydrocolloid DressingFRO · Traditional | 05/20/1994SN |
| K941005 | Dermassist(Tm) Xeroform Petrolatum DressingFRO · Traditional | 04/14/1994SN |
| K940076 | Dermassist Wet Dressing, WaterFRO · Traditional | 03/03/1994SE |
| K940044 | Dermassist Wet Dressing, SalineFRO · Traditional | 03/03/1994SE |
| K936234 | Dermassist Oil Emulsion Non-Adhering Wound DressingFRO · Traditional | 03/03/1994SE |
| K936230 | Dermassist Petrolatum Gauze,UspFRO · Traditional | 03/03/1994SE |
| K935796 | Hydroderm Breathable Transparent DressingMGP · Traditional | 02/02/1994SE |
Questions and answers
When was Dermassist(Tm) Hydrogel Saturated Gauze Dressing cleared by the FDA?
Dermassist(Tm) Hydrogel Saturated Gauze Dressing (K946030) received a 510(k) decision of Substantially Equivalent on February 27, 1995, 80 days after the submission was received.
What is the product code of K946030?
The FDA product code is MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, a Unclassified device.