Cleared Traditional

VILA-COOKE(TM) ANESTHESIA PILLOW

K932305 · Sharn, Inc. · Anesthesiology

Oct 1993

Decision

146d

Days

Class 1

Risk

About This 510(k) Submission

K932305 is an FDA 510(k) clearance for the VILA-COOKE(TM) ANESTHESIA PILLOW, a Support, Patient Position (Class I — General Controls, product code CCX), submitted by Sharn, Inc. (Tampa, US). The FDA issued a Cleared decision on October 5, 1993, 146 days after receiving the submission on May 12, 1993. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.6820.

Submission Details

510(k) Number	K932305 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 12, 1993
Decision Date	October 05, 1993
Days to Decision	146 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF