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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stent, Ureteral
510(k) Number K854862
Device Name CURITY URETERAL STENT
Applicant
The Kendal Co.
One Federal St.
Boston,  MA  02110
Applicant Contact CHRISTINE MORGIDA
Correspondent
The Kendal Co.
One Federal St.
Boston,  MA  02110
Correspondent Contact CHRISTINE MORGIDA
Regulation Number876.4620
Classification Product Code
FAD  
Date Received12/05/1985
Decision Date 02/10/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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