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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 K872826
Device Name ULTRA-NEB 99 ULTRASONIC NEBULIZER
Applicant
THE DEVILBISS CO.
P.O. BOX 635
SOMERSET,  PA  15501
Applicant Contact TERRENCE M O'BRIEN
Correspondent
THE DEVILBISS CO.
P.O. BOX 635
SOMERSET,  PA  15501
Correspondent Contact TERRENCE M O'BRIEN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received07/16/1987
Decision Date 09/04/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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