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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K980282
Device Name URESIL DILATOR WITH RADIOPAQUE MARKER
Applicant
Uresil Corp.
5418 W. Touhy Ave.
Skokie,  IL  60077
Applicant Contact LEV MELINYSHYN
Correspondent
Uresil Corp.
5418 W. Touhy Ave.
Skokie,  IL  60077
Correspondent Contact LEV MELINYSHYN
Regulation Number870.1310
Classification Product Code
DRE  
Date Received01/26/1998
Decision Date 04/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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