Cleared Traditional

TOPICAL APPLICATOR

K070596 · Sharn, Inc. · Anesthesiology

Jun 2007

Decision

111d

Days

Class 2

Risk

About This 510(k) Submission

K070596 is an FDA 510(k) clearance for the TOPICAL APPLICATOR, a Applicator (laryngo-tracheal), Topical Anesthesia (Class II — Special Controls, product code CCT), submitted by Sharn, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on June 21, 2007, 111 days after receiving the submission on March 2, 2007. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5170.

Submission Details

510(k) Number	K070596 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 02, 2007
Decision Date	June 21, 2007
Days to Decision	111 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF