Hylatopic Emollient Foam

FDA 510(k) K083024 · Collegium Pharmaceutical Incorporated

Substantially Equivalent

510(k) numberK083024

Submission

Device name
Hylatopic Emollient Foam
Applicant
Collegium Pharmaceutical Incorporated
Cumberland, RI, US
Received
October 9, 2008
Decision date
March 27, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Device class
Unclassified

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Questions and answers

When was Hylatopic Emollient Foam cleared by the FDA?

Hylatopic Emollient Foam (K083024) received a 510(k) decision of Substantially Equivalent on March 27, 2009, 169 days after the submission was received.

What is the product code of K083024?

The FDA product code is MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, a Unclassified device.