A Gel Wound Dressing
FDA 510(k) K951862 · Polymedica Industries, Inc.
510(k) numberK951862
Submission
- Device name
- A Gel Wound Dressing
- Applicant
- Polymedica Industries, Inc.
Golden,, CO, US - Received
- April 21, 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
- MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- Device class
- Unclassified
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| K041342 | Impruv A.I. Cream Wound and Skin EmulsionMGQ · Traditional | Stiefel Laboratories, Inc. | 07/19/2005SE |
| K041268 | Silversite or CalgitrolMGQ · Traditional | Adri | 09/20/2004SE |
| K040019 | SilversealMGQ · Traditional | Noble Fiber Technologies | 07/23/2004SE |
| K040517 | Tenderwet ActiveMGQ · Traditional | Medline Industries, Inc. | 03/25/2004SE |
| K022587 | Medtrade Product's Antiseptic Barrier Hydrogel DressingsMGQ · Traditional | Medtrade Products , Ltd. | 08/22/2003SE |
| 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 |
|---|---|---|
| K964398 | Spyroflex Pigmented Wound Dressing/Spyroflex Wound Dressing TintedMGP · Traditional | 10/24/1997SE |
| K971045 | Basis Flexible Tip Digital ThermometerFLL · Traditional | 05/02/1997SE |
| K964701 | Mitraflex Pigmented Wound DressingFRO · Traditional | 02/07/1997SE |
| K963623 | Spyroflex Pigmented Wound DressingMGP · Traditional | 10/25/1996SE |
| K962991 | Basis Baby-Temp Pacifier Digital TherometerFLL · Traditional | 09/12/1996SE |
| K955383 | Spyrocolloid Wound DressingMGP · Traditional | 12/13/1995SN |
| K953885 | Spyroflex Skin ProtectorMGP · Traditional | 11/29/1995SE |
| K952756 | Medi-Aid Basal ThermometerLHD · Traditional | 09/25/1995SE |
| K952159 | Basis Digital ThermometerFLL · Traditional | 09/22/1995SE |
| K953618 | Spyroflex Wound DressingMGP · Traditional | 08/21/1995SN |
Questions and answers
When was A Gel Wound Dressing cleared by the FDA?
A Gel Wound Dressing (K951862) received a 510(k) decision of Substantially Equivalent on July 12, 1995, 82 days after the submission was received.
What is the product code of K951862?
The FDA product code is MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, a Unclassified device.