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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 K150044
Device Name O-PEP
Applicant
Pari Respiratory Equipment, Inc.
2412 Pari Way
Midlothian,  VA  23112
Applicant Contact Michael Judge
Correspondent
Pari Respiratory Equipment, Inc.
2412 Pari Way
Midlothian,  VA  23112
Correspondent Contact Michael Judge
Regulation Number868.5690
Classification Product Code
BWF  
Date Received01/12/2015
Decision Date 05/27/2016
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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