Cleared Traditional

K942827 - SENTRY INSERTION TRAY
(FDA 510(k) Clearance)

K942827 · Sentry Medical Products, Inc. · General Hospital

Nov 1994

Decision

141d

Days

Class 2

Risk

K942827 is an FDA 510(k) clearance for the SENTRY INSERTION TRAY. This device is classified as a Catheter, Umbilical Artery (Class II — Special Controls, product code FOS).

Submitted by Sentry Medical Products, Inc. (Lombard, US). The FDA issued a Cleared decision on November 2, 1994, 141 days after receiving the submission on June 14, 1994.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K942827 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 14, 1994
Decision Date	November 02, 1994
Days to Decision	141 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement