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510(k) K933957

Device
DILATING URETHRAL SOUND
Applicant
COOK UROLOGICAL, INC.
510(k) number
K933957
Product code
FAH  
Decision
Substantially Equivalent (SESE)
Decision date
1993-11-17
Date received
1993-08-12
Regulation
876.5520
Classification name
Dilator, Urethral, Mechanical
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
TAMMY BACON
Address
1100 W. Morgan St. P.O. Box 227 Spencer IN US 47460 47460

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FAH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K902370MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETERBoston Scientific Corp1990-08-17
K902124DOWD CATHETERBoston Scientific Corp1990-08-09
K831384COAXIAL BALLOON URETHRAL DILATORThomas J. Fogarty, M.D.1983-07-26

Legacy Summary#

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FDA Review#

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