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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 K991898
Device Name ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE
Applicant
Microvena Corp.
1861 Buerkle Rd.
White Bear Lake,  MN  55110 -5426
Applicant Contact ANGELA MALLERY
Correspondent
Microvena Corp.
1861 Buerkle Rd.
White Bear Lake,  MN  55110 -5426
Correspondent Contact ANGELA MALLERY
Regulation Number870.1330
Classification Product Code
DQX  
Date Received06/04/1999
Decision Date 06/16/1999
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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