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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter And Tip, Suction
510(k) Number K872948
Device Name URESIL THORA-FLO THORACENTESIS PROCEDURE KIT
Applicant
Uresil Corp.
5418 W. Touhy Ave.
Skokie,  IL  60077
Applicant Contact MICHAEL JARON
Correspondent
Uresil Corp.
5418 W. Touhy Ave.
Skokie,  IL  60077
Correspondent Contact MICHAEL JARON
Regulation Number880.6740
Classification Product Code
JOL  
Date Received07/28/1987
Decision Date 11/27/1987
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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