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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 K163091
Device Name VibraPEP
Medica Holdings, LLC
5200 Meadows Road
Suite 150
Lake Osego,  OR  97035
Applicant Contact George Reed
ProMedic, LLC
24301 Woodsage Dr.
Bonita Springs,  FL  34134
Correspondent Contact Paul Dryden
Regulation Number868.5690
Classification Product Code
Date Received11/04/2016
Decision Date 02/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No