HylaGuard Moisturizing Cream— 510(k) K171879

Name: FDA 510(k) clearance K171879
Creator: U.S. Food and Drug Administration
Published: 2017-10-16

Substantially Equivalent

Founders Science Group, LLC

FDA 510(k) clearance K171879 for HylaGuard Moisturizing Cream, Substantially Equivalent on 2017-10-16. Applicant: Founders Science Group, LLC. Device class: Unclassified.

Clearance details

Applicant: Founders Science Group, LLC
Product code: Code MGQ
Device class: Unclassified
Advisory panel: Unknown
Date received: 2017-06-23
Decision date: 2017-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taunton, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MGQ

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K083024 — HYLATOPIC EMOLLIENT FOAM2009-03-27
K041342 — IMPRUV A.I. CREAM WOUND AND SKIN EMULSION2005-07-19
K041268 — SILVERSITE OR CALGITROL2004-09-20
K040019 — SILVERSEAL2004-07-23
K040517 — TENDERWET ACTIVE2004-03-25

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K150914 — Dash-Topic Plus Cream2016-04-21

Adverse events under product code MGQ

product code MGQ

Death: 16
Total: 16

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.