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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 K904718
Device Name AERO-GEN NUBULIZER SYSTEM
Applicant
TRI/BOR MEDICAL, INC.
P.O. BOX 419
WESTTOWN,  NY  10998
Applicant Contact KATHLEEN MIRESSI
Correspondent
TRI/BOR MEDICAL, INC.
P.O. BOX 419
WESTTOWN,  NY  10998
Correspondent Contact KATHLEEN MIRESSI
Regulation Number868.5630
Classification Product Code
CAF  
Date Received10/18/1990
Decision Date 04/01/1991
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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