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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 K021990
Device Name GALT MEDICAL GUIDEWIRE
Applicant
GALT MEDICAL CORP.
2475 MERRITT DR.
GARLAND,  TX  75041
Applicant Contact DAVID CATLIN
Correspondent
GALT MEDICAL CORP.
2475 MERRITT DR.
GARLAND,  TX  75041
Correspondent Contact DAVID CATLIN
Regulation Number870.1330
Classification Product Code
DQX  
Date Received06/18/2002
Decision Date 07/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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