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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cpb Check Valve, Retrograde Flow, In-Line
510(k) Number K182442
Device Name MiniGuard Arterial Safety Valve
Applicant
Quest Medical, Inc.
One Allentown Pkwy.
Allen,  TX  75002
Applicant Contact Tosan Onosode
Correspondent
Quest Medical, Inc.
One Allentown Pkwy.
Allen,  TX  75002
Correspondent Contact Tosan Onosode
Regulation Number870.4400
Classification Product Code
MJJ  
Date Received09/07/2018
Decision Date 11/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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