Cleared Traditional

IMPRUV A.I. CREAM WOUND AND SKIN EMULSION

K041342 · Stiefel Laboratories, Inc. · General & Plastic Surgery

Jul 2005

Decision

425d

Days

—

Risk

About This 510(k) Submission

K041342 is an FDA 510(k) clearance for the IMPRUV A.I. CREAM WOUND AND SKIN EMULSION, a Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic, submitted by Stiefel Laboratories, Inc. (Oak Hill, US). The FDA issued a Cleared decision on July 19, 2005, 425 days after receiving the submission on May 20, 2004. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number	K041342 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 20, 2004
Decision Date	July 19, 2005
Days to Decision	425 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF