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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 K063819
Device Name ASAHI PTCA GUIDE WIRE, FIELDER FC
Applicant
Asahi Intecc Co., Ltd.
1301 Dove St., Suite #350
Newport Beach,  CA  92660
Applicant Contact YOSHI TERAI
Correspondent
Asahi Intecc Co., Ltd.
1301 Dove St., Suite #350
Newport Beach,  CA  92660
Correspondent Contact YOSHI TERAI
Regulation Number870.1330
Classification Product Code
DQX  
Date Received12/26/2006
Decision Date 01/26/2007
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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