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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 K142516
Device Name Propeller System
Applicant
RECIPROCAL LABS CORPORATION
634 W Main St Ste 102
Madison,  WI  53703
Applicant Contact David Hubanks
Correspondent
RECIPROCAL LABS CORPORATION
634 W Main St Ste 102
Madison,  WI  53703
Correspondent Contact David Hubanks
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/08/2014
Decision Date 05/15/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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