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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
Applicant
Reciprocal Labs Corporation
612 W. Main St.
Suite 201
Madison,  WI  53703
Applicant Contact INGER L COUTURE
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number868.5630
Classification Product Code
CAF  
Date Received06/01/2012
Decision Date 07/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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