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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 K910280
Device Name ULTRA-SELECT PTCA GUIDEWIRE
Applicant
Microvena Corp.
6470 Riverview Ter.
Findley,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
Microvena Corp.
6470 Riverview Ter.
Findley,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number870.1330
Classification Product Code
DQX  
Date Received01/23/1991
Decision Date 04/19/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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