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510(k) K852083

Device
THE KENDALL URINARY OUTPUT MONITOR
Applicant
THE KENDAL CO.
510(k) number
K852083
Product code
FFO  
Decision
Substantially Equivalent (SESE)
Decision date
1985-09-20
Date received
1985-05-13
Regulation
876.4730
Classification name
Retractor, Self-retaining
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MARK W WENZEL
Address
One Federal St. Boston MA US 02110 02110

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FFO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K993544SPACE-OR RETRACTORAdvanced Surgical Concepts (Asc)1999-12-22
K870897KODNER ANAL PERIONEAL RETRACTORSur-Med Instruments, Inc.1987-06-04
K860368URDYN 5000 (UROFLOWMETER)Dantec Electronics, Inc.1986-04-23
K853119URODYN 1000Dantec Electronics, Inc.1985-10-04

Legacy Summary#

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FDA Review#

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