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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 K013024
Device Name SELECTIVA GUIDEWIRE
Applicant
Neometrics, Inc.
15301 Highway 55 W.
Minneapolis,  MN  55447
Applicant Contact GENE CHAMPEAU
Correspondent
Neometrics, Inc.
15301 Highway 55 W.
Minneapolis,  MN  55447
Correspondent Contact GENE CHAMPEAU
Regulation Number870.1330
Classification Product Code
DQX  
Date Received09/07/2001
Decision Date 12/04/2001
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
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