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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor, Self-Retaining
510(k) Number K852083
Device Name THE KENDALL URINARY OUTPUT MONITOR
Applicant
The Kendal Co.
One Federal St.
Boston,  MA  02110
Applicant Contact MARK W WENZEL
Correspondent
The Kendal Co.
One Federal St.
Boston,  MA  02110
Correspondent Contact MARK W WENZEL
Regulation Number876.4730
Classification Product Code
FFO  
Date Received05/13/1985
Decision Date 09/20/1985
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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