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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 K945934
Device Name URESIL(R) GUIDEWIRE
Applicant
Uresil Corp.
5418 W. Touhy Ave.
Skokie,  IL  60077
Applicant Contact MATTHEW CURTIS
Correspondent
Uresil Corp.
5418 W. Touhy Ave.
Skokie,  IL  60077
Correspondent Contact MATTHEW CURTIS
Regulation Number870.1330
Classification Product Code
DQX  
Date Received12/05/1994
Decision Date 07/10/1995
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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