Impruv A.I. Cream Wound and Skin Emulsion

FDA 510(k) K041342 · Stiefel Laboratories, Inc.

Substantially Equivalent

510(k) numberK041342

Submission

Device name
Impruv A.I. Cream Wound and Skin Emulsion
Applicant
Stiefel Laboratories, Inc.
Oak Hill, NY, US
Received
May 20, 2004
Decision date
July 19, 2005
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 Impruv A.I. Cream Wound and Skin Emulsion cleared by the FDA?

Impruv A.I. Cream Wound and Skin Emulsion (K041342) received a 510(k) decision of Substantially Equivalent on July 19, 2005, 425 days after the submission was received.

What is the product code of K041342?

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