Cleared Traditional

SINCLAIR WOUND AND SKIN EMULSION

K024367 · Sinclair Pharmaceuticals, Ltd. · General & Plastic Surgery
Jul 2003
Decision
209d
Days
Risk

About This 510(k) Submission

K024367 is an FDA 510(k) clearance for the SINCLAIR WOUND AND SKIN EMULSION, a Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic, submitted by Sinclair Pharmaceuticals, Ltd. (Godalming, Surrey, GB). The FDA issued a Cleared decision on July 28, 2003, 209 days after receiving the submission on December 31, 2002. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K024367 FDA.gov
FDA Decision Cleared SESE
Date Received December 31, 2002
Decision Date July 28, 2003
Days to Decision 209 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code MGQ — Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class

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