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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K200324
Device Name NHancer Rx
Applicant
Imds Operations B.V.
Ceintuurbaan Noord 150
Roden,  NL 9301 NA
Applicant Contact E Schulting
Correspondent
Imds Operations B.V.
Ceintuurbaan Noord 150
Roden,  NL 9301 NA
Correspondent Contact E. Schulting
Regulation Number870.1250
Classification Product Code
DQY  
Date Received02/10/2020
Decision Date 08/06/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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