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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tent, Oxygen
510(k) Number K882396
Device Name AEROSOL DELIVERY HOOD
Applicant
Viratek, Inc.
Icn Plz.
3300 Hyland Ave.
Costa Mesa,  CA  92626
Applicant Contact JOSEPH CREIGHTON
Correspondent
Viratek, Inc.
Icn Plz.
3300 Hyland Ave.
Costa Mesa,  CA  92626
Correspondent Contact JOSEPH CREIGHTON
Regulation Number868.5700
Classification Product Code
BYL  
Date Received06/10/1988
Decision Date 08/01/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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