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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 K982559
Device Name GUIDEWIRE
Applicant
Galt Medical Corp.
2475 Merritt Dr.
Garland,  TX  75041
Applicant Contact JIM EDINGS
Correspondent
Galt Medical Corp.
2475 Merritt Dr.
Garland,  TX  75041
Correspondent Contact JIM EDINGS
Regulation Number870.1330
Classification Product Code
DQX  
Date Received07/23/1998
Decision Date 02/01/1999
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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