Cleared Traditional

HOOD, OPERATING, SURGICAL

K904969 · Chicago Assoc. For Retarded Citizens · General Hospital

Dec 1990

Decision

37d

Days

Class 2

Risk

About This 510(k) Submission

K904969 is an FDA 510(k) clearance for the HOOD, OPERATING, SURGICAL, a Hood, Surgical (Class II — Special Controls, product code FXY), submitted by Chicago Assoc. For Retarded Citizens (Chicago, US). The FDA issued a Cleared decision on December 12, 1990, 37 days after receiving the submission on November 5, 1990. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K904969 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 05, 1990
Decision Date	December 12, 1990
Days to Decision	37 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—