Cleared Traditional

ALOCLAIR ORAL GEL

K040950 · Sinclair Pharmaceuticals, Ltd. · General & Plastic Surgery

Jun 2004

Decision

70d

Days

—

Risk

About This 510(k) Submission

K040950 is an FDA 510(k) clearance for the ALOCLAIR ORAL GEL, a Oral Wound Dressing, submitted by Sinclair Pharmaceuticals, Ltd. (Carrollton, US). The FDA issued a Cleared decision on June 21, 2004, 70 days after receiving the submission on April 12, 2004. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number	K040950 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 12, 2004
Decision Date	June 21, 2004
Days to Decision	70 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	OLR — Oral Wound Dressing
Device Class	—
Definition	Intended As A Physical Barrier For Temporary Protection Of Oral Mucosal Tissue And To Provide Pain Relief. Unclassified Status Per Se To Mgq.