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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 K964078
Device Name 3050 SPORT-NEB
Applicant
Medical Industries America, Inc.
2879 "R" Ave.
Adel,  IA  50003
Applicant Contact RUSSELL F BIRD
Correspondent
Medical Industries America, Inc.
2879 "R" Ave.
Adel,  IA  50003
Correspondent Contact RUSSELL F BIRD
Regulation Number868.5630
Classification Product Code
CAF  
Date Received10/11/1996
Decision Date 01/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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