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510(k) K860368

Device
URDYN 5000 (UROFLOWMETER)
Applicant
DANTEC ELECTRONICS, INC.
510(k) number
K860368
Product code
FFO  
Decision
Substantially Equivalent (SESE)
Decision date
1986-04-23
Date received
1986-02-03
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
HENRIK HENRIKSEN
Address
6 Pearl Ct. Allendale NJ US 07401 07401

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
K853119URODYN 1000Dantec Electronics, Inc.1985-10-04
K852083THE KENDALL URINARY OUTPUT MONITORThe Kendal Co.1985-09-20

Legacy Summary#

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FDA Review#

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