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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 K901315
Device Name AEROMIST II NEBULIZER
Applicant
Inhalation Plastics
7790 N. Merrimac
Chicago,  IL  60648
Applicant Contact JAMES LEKKAS
Correspondent
Inhalation Plastics
7790 N. Merrimac
Chicago,  IL  60648
Correspondent Contact JAMES LEKKAS
Regulation Number868.5630
Classification Product Code
CAF  
Date Received03/21/1990
Decision Date 09/10/1990
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
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