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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 K896375
Device Name PREEMICARE NEBUTECH NEBULIZER SYSTEM
Applicant
PREEMICARE CORP.
3300 WALNUT BEND LN.
HOUSTON,  TX  77042
Applicant Contact CHARLES BOYD
Correspondent
PREEMICARE CORP.
3300 WALNUT BEND LN.
HOUSTON,  TX  77042
Correspondent Contact CHARLES BOYD
Regulation Number868.5630
Classification Product Code
CAF  
Date Received11/06/1989
Decision Date 10/29/1990
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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