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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 K760442
Device Name NEBULIZER ADAPTER (AERMIST)
Applicant
AERWAY LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AERWAY LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5630
Classification Product Code
CAF  
Date Received08/16/1976
Decision Date 08/26/1976
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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