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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 K140638
Device Name PROPELLER SYSTEM - MODEL 2
Applicant
RECIPROCAL LABS CORPORATION
634 W Main St Ste 102
Madison,  WI  53703
Applicant Contact J. DAVID SICKLE
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number868.5630
Classification Product Code
CAF  
Date Received03/12/2014
Decision Date 05/02/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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