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510(k) K831384

Device
COAXIAL BALLOON URETHRAL DILATOR
Applicant
THOMAS J. FOGARTY, M.D.
510(k) number
K831384
Product code
FAH  
Decision
Substantially Equivalent (SESE)
Decision date
1983-07-26
Date received
1983-04-28
Regulation
876.5520
Classification name
Dilator, Urethral, Mechanical
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 FAH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K933957DILATING URETHRAL SOUNDCook Urological, Inc.1993-11-17
K902370MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETERBoston Scientific Corp1990-08-17
K902124DOWD CATHETERBoston Scientific Corp1990-08-09

Legacy Summary#

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FDA Review#

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