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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, nonabsorbable, synthetic, polyamide
510(k) Number K920510
Device Name URESIL LOCKING GENERAL PURPOSE DRAINAGE CATHETER
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 Number878.5020
Classification Product Code
GAR  
Date Received02/02/1992
Decision Date 09/14/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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