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510(k) K000905

Device
URETHROTOME 8667.XXX AND 8670.XXX
Applicant
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
510(k) number
K000905
Product code
EZO  
Decision
Substantially Equivalent (SESE)
Decision date
2000-05-12
Date received
2000-03-21
Regulation
876.4770
Classification name
Urethrotome
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
ROBERT L CASARSA
Address
353 Corporate Woods Pkwy. Vernon Hills IL US 60061 60061

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EZO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K950719OES UROLOGYOlympus America, Inc.1996-12-11
K945686KARL STORZ KNIVES, CURETTESKARL STORZ Endoscopy-America, Inc.1995-02-13
K934730KARL STORZ ENDOSCOPIC COLD KNIFE BLADESKARL STORZ Endoscopy-America, Inc.1994-01-11
K904939FLEXIBLE AND RIGID URETEROTOME SYSTEMOlympus Corp.1992-01-07

Legacy Summary#

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FDA Review#

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