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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 K841926
Device Name HYDROGLIDE SPRING GUIDE WIRES
Applicant
Argon Medical Corp.
P.O. Box 1970
Athens,  TX  75751
Applicant Contact VAN HINE
Correspondent
Argon Medical Corp.
P.O. Box 1970
Athens,  TX  75751
Correspondent Contact VAN HINE
Regulation Number870.1330
Classification Product Code
DQX  
Date Received05/10/1984
Decision Date 01/02/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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