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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K860484
Device Name CURITY & KENGUARD SILICONE COATED FOLEY CATHETER
Applicant
The Kendal Co.
One Federal St.
Boston,  MA  02110 -2003
Applicant Contact CHRISTINE MORGIDA
Correspondent
The Kendal Co.
One Federal St.
Boston,  MA  02110 -2003
Correspondent Contact CHRISTINE MORGIDA
Regulation Number876.5130
Classification Product Code
KOD  
Date Received02/10/1986
Decision Date 03/11/1986
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
Recalls CDRH Recalls
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