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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K160785
Device Name Worker Guidewire
Applicant
Argon Medical Devices, Inc.
1445 Flat Creek Rd.
Athens,  TX  75751
Applicant Contact SUZANNE CHEANG
Correspondent
Argon Medical Devices, Inc.
1445 Flat Creek Rd.
Athens,  TX  75751
Correspondent Contact SUZANNE CHEANG
Regulation Number870.1330
Classification Product Code
DQX  
Date Received03/22/2016
Decision Date 12/08/2016
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
Recalls CDRH Recalls
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