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510(k) K900016

Device
TRANS/R - FP(3)
Applicant
CIVCO MEDICAL INSTRUMENTS CO., INC.
510(k) number
K900016
Product code
FCY  
Decision
Substantially Equivalent (SESE)
Decision date
1990-06-11
Date received
1990-01-02
Regulation
876.1500
Classification name
Bulb, Inflation, For Endoscope
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
J WEDEL
Address
418 B Ave. Kalona IA US 52247 52247

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FCY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K093718ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003Zutron Medical, LLC2010-02-22
K904376ANEROID BLOOD PRESSURE GAUGEBiomedical Dynamics, Inc.1990-12-20

Legacy Summary#

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FDA Review#

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