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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Therapeutic (Incentive)
510(k) Number K160636
Device Name iPEP System and vPEP
Applicant
D R Burton Healthcare, LLC
3936 S Fields St.
Farmville,  NC  27828
Applicant Contact DENNIS COOK
Correspondent
D R Burton Healthcare, LLC
3936 S Fields St.
Farmville,  NC  27828
Correspondent Contact PAUL DRYDEN
Regulation Number868.5690
Classification Product Code
BWF  
Date Received03/07/2016
Decision Date 08/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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