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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stripper, Vein, External
510(k) Number K905528
Device Name URESIL VALVE CUTTER
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 Number870.4885
Classification Product Code
DWQ  
Date Received12/10/1990
Decision Date 04/18/1991
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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