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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Pressure, Catheter Tip
510(k) Number K190852
Device Name Zurich Pressure Guidewire System Model 100
Applicant
Zurich Medical, Inc.
2405 Xenium Ln. N
Plymouth,  MN  55441
Applicant Contact Kin-Joe Sham
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.2870
Classification Product Code
DXO  
Subsequent Product Codes
DQK   DQX   DSK  
Date Received04/02/2019
Decision Date 08/14/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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