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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 K903569
Device Name CURITY THORACENTESIS TRAY
Applicant
Kendall Healthcare Products Co. Div.Of Tyco Health
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact JOHN J VOZELLA
Correspondent
Kendall Healthcare Products Co. Div.Of Tyco Health
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact JOHN J VOZELLA
Regulation Number880.6740
Classification Product Code
JOL  
Date Received08/07/1990
Decision Date 09/07/1990
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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