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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 K153441
Device Name VibraPEP
Applicant
Medica Holdings, LLC
5200 Meadows Road, Suite 150
Lake Oswego,  OR  97035
Applicant Contact George Reed
Correspondent
Medica Holdings, LLC
5200 Meadows Road, Suite 150
Lake Oswego,  OR  97035
Correspondent Contact Paul Dryden
Regulation Number868.5690
Classification Product Code
BWF  
Date Received11/27/2015
Decision Date 03/25/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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