Cleared Traditional

K942529 - HCI TUBE STABILIZER
(FDA 510(k) Clearance)

K942529 · Health Care Contracts, Inc. · Anesthesiology

Jun 1995

Decision

383d

Days

Class 1

Risk

K942529 is an FDA 510(k) clearance for the HCI TUBE STABILIZER. This device is classified as a Device, Fixation, Tracheal Tube (Class I — General Controls, product code CBH).

Submitted by Health Care Contracts, Inc. (San Antonio, US). The FDA issued a Cleared decision on June 14, 1995, 383 days after receiving the submission on May 27, 1994.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5770.

Submission Details

510(k) Number	K942529 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 1994
Decision Date	June 14, 1995
Days to Decision	383 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement