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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K870051
Device Name SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLE
Applicant
VIRATEK, INC.
ICN PLAZA
3300 HYLAND AVENUE
COSTA MESA,  CA  92626
Applicant Contact STAFFA, PHD
Correspondent
VIRATEK, INC.
ICN PLAZA
3300 HYLAND AVENUE
COSTA MESA,  CA  92626
Correspondent Contact STAFFA, PHD
Regulation Number868.5630
Classification Product Code
CAF  
Date Received01/06/1987
Decision Date 10/06/1987
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
Recalls CDRH Recalls
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