AEROSOL DELIVERY HOOD

Tent, Oxygen

VIRATEK, INC.

The following data is part of a premarket notification filed by Viratek, Inc. with the FDA for Aerosol Delivery Hood.

Pre-market Notification Details

Device IDK882396
510k NumberK882396
Device Name:AEROSOL DELIVERY HOOD
ClassificationTent, Oxygen
Applicant VIRATEK, INC. ICN PLAZA 3300 HYLAND AVENUE Costa Mesa,  CA  92626
ContactJoseph Creighton
CorrespondentJoseph Creighton
VIRATEK, INC. ICN PLAZA 3300 HYLAND AVENUE Costa Mesa,  CA  92626
Product CodeBYL  
CFR Regulation Number868.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-06-10
Decision Date1988-08-01

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