HylaGuard Moisturizing Cream
FDA 510(k) K171879 · Founders Science Group, LLC
510(k) numberK171879
Submission
- Device name
- HylaGuard Moisturizing Cream
- Applicant
- Founders Science Group, LLC
Taunton, MA, US - Received
- June 23, 2017
- Decision date
- October 16, 2017
- 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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|---|---|---|---|
| K083024 | Hylatopic Emollient FoamMGQ · Traditional | Collegium Pharmaceutical Incorporated | 03/27/2009SE |
| 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 |
| K022995 | Collatek HydrogelMGQ · Traditional | Biocore Medical Technologies, Inc. | 12/02/2002SE |
More from Biocore Medical Technologies, Inc.
| 510(k) | Device | Decision |
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| K150914 | Dash-Topic Plus CreamFRO · Traditional | 04/21/2016SE |
Questions and answers
When was HylaGuard Moisturizing Cream cleared by the FDA?
HylaGuard Moisturizing Cream (K171879) received a 510(k) decision of Substantially Equivalent on October 16, 2017, 115 days after the submission was received.
What is the product code of K171879?
The FDA product code is MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, a Unclassified device.