HYLATOPIC EMOLLIENT FOAM— 510(k) K083024

Substantially Equivalent

Collegium Pharmaceutical Incorporated

FDA 510(k) clearance K083024 for HYLATOPIC EMOLLIENT FOAM, Substantially Equivalent on 2009-03-27. Applicant: Collegium Pharmaceutical Incorporated.

Clearance details

Applicant: Collegium Pharmaceutical Incorporated
Product code: Code MGQ
Advisory panel: Unknown
Date received: 2008-10-09
Decision date: 2009-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cumberland, RI, US

Download summary PDF View on FDA.gov ↗

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.