Cleared Traditional

K992702 - EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM
(FDA 510(k) Clearance)

K992702 · Allergy Direct · General Hospital

Nov 1999

Decision

88d

Days

Class 1

Risk

K992702 is an FDA 510(k) clearance for the EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM, a Cover, Mattress (medical Purposes) (Class I — General Controls, product code FMW), submitted by Allergy Direct (Kansas City, US). The FDA issued a Cleared decision on November 8, 1999, 88 days after receiving the submission on August 12, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6190.

Submission Details

510(k) Number	K992702 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 12, 1999
Decision Date	November 08, 1999
Days to Decision	88 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF