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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K191270
Device Name Proneb Max
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 Number868.5630
Classification Product Code
CAF  
Subsequent Product Code
BTI  
Date Received05/13/2019
Decision Date 01/23/2020
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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