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510(k) K833061

Device
C-FLEX PENROSE DRAINAGE TUBE
Applicant
CONCEPT, INC.
510(k) number
K833061
Product code
FFA  
Decision
Substantially Equivalent (SESE)
Decision date
1983-11-07
Date received
1983-09-09
Regulation
876.5090
Classification name
Tube, Drainage, Suprapubic
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FFA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K944290CATHETERS, BILIARY CATHETERS, UROLOGICALBoston Scientific Corp1994-12-08
K864770SUCTION TUBENew England Surgical Instrument Corp.1987-02-24

Legacy Summary#

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FDA Review#

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