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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apparatus, suction, patient care
510(k) Number K190292
Device Name Passio Pump Drainage System
Applicant
Bearpac Medical
124 West Point Road
Moultonborough,  NH  03254
Applicant Contact Jay Zimmerman
Correspondent
Bearpac Medical
124 West Point Road
Moultonborough,  NH  03254
Correspondent Contact Jay Zimmerman
Regulation Number870.5050
Classification Product Code
DWM  
Date Received02/11/2019
Decision Date 07/25/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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