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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 K900273
Device Name TRACH CARE MDI ADAPTER
Applicant
Ballard Medical Products
6864 S. 300 W.
Midvale,  UT  84047
Applicant Contact MARTIN CHAMBERLAIN
Correspondent
Ballard Medical Products
6864 S. 300 W.
Midvale,  UT  84047
Correspondent Contact MARTIN CHAMBERLAIN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received01/19/1990
Decision Date 08/29/1990
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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