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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 K943990
Device Name 3000 AEROSOL TWO
Applicant
Medical Industries America, Inc.
2879 R Ave.
Adel,  IA  50003
Applicant Contact MARK D HEBENSTEIT
Correspondent
Medical Industries America, Inc.
2879 R Ave.
Adel,  IA  50003
Correspondent Contact MARK D HEBENSTEIT
Regulation Number868.5630
Classification Product Code
CAF  
Date Received08/16/1994
Decision Date 03/21/1995
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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