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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oxygenator, cardiopulmonary bypass
510(k) Number K201642
Device Name Paragon Adult Maxi PMP Oxygenator with Tubing Pack
Applicant
Chalice Medical Ltd
Manton Wood Enterprise Park
Worksop,  GB S80 2RS
Applicant Contact Stephen Horan
Correspondent
Chalice Medical Ltd
Manton Wood Enterprise Park
Worksop,  GB S80 2RS
Correspondent Contact Stephen Horan
Regulation Number870.4350
Classification Product Code
DTZ  
Subsequent Product Codes
DTR   DWF  
Date Received06/17/2020
Decision Date 09/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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