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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 K111570
Model 1024A, 1025A, 1543A
Device Name MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR
Original Applicant
THAYER MEDICAL CORPORATION
4575 south palo verde road
suite 337
tucson,  AZ  85714 1961
Original Contact erika s strickland
Regulation Number868.5630
Classification Product Code
CAF  
Date Received06/06/2011
Decision Date 09/29/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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