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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 K121609
Device Name ASTHMAPOLIS SYSTEM
Original Applicant
RECIPROCAL LABS CORPORATION
612 w. main street
ste. 201
madison,  WI  53703
Original Contact inger l couture
Regulation Number868.5630
Classification Product Code
CAF  
Date Received06/01/2012
Decision Date 07/02/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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