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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
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