EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM— 510(k) K992702

Name: FDA 510(k) clearance K992702
Creator: U.S. Food and Drug Administration
Published: 1999-11-08

Substantially Equivalent

Allergy Direct

FDA 510(k) clearance K992702 for EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM, Substantially Equivalent on 1999-11-08. Applicant: Allergy Direct. Device class: 1.

Clearance details

Applicant: Allergy Direct
Product code: Code FMW
Device class: Class 1
Regulation: 21 CFR 880.6190
Advisory panel: General Hospital
Date received: 1999-08-12
Decision date: 1999-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, MO, US

Download summary PDF View on FDA.gov ↗

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