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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 K181660
Device Name Acapella Choice Blue Vibratory PEP Device
Applicant
Smiths Medical
6000 Nathan Lane North
Minneapolis,  MN  55442
Applicant Contact Donna Semlak
Correspondent
MRC-X, LLC
6075 Poplar Avenue, Suite 500
Memphis,  TN  38119
Correspondent Contact Dawn Norman
Regulation Number868.5690
Classification Product Code
BWF  
Date Received06/25/2018
Decision Date 10/24/2019
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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