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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 K981936
Device Name ABD VARISOFT STEERABLE GUIDE WIRE AND ABD VARISOFT GUIDE WIRE EXTENSION
Applicant
Advanced Biomedical Devices, Inc.
3 Dundee Park
Andover,  MA  01810
Applicant Contact R. EDWARD WINTERS
Correspondent
Advanced Biomedical Devices, Inc.
3 Dundee Park
Andover,  MA  01810
Correspondent Contact R. EDWARD WINTERS
Regulation Number870.1330
Classification Product Code
DQX  
Date Received06/02/1998
Decision Date 02/16/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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