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510(k) K950719

Device
OES UROLOGY
Applicant
OLYMPUS AMERICA, INC.
510(k) number
K950719
Product code
EZO  
Decision
Substantially Equivalent (SESE)
Decision date
1996-12-11
Date received
1995-02-16
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
BARRY E SANDS
Address
4 Nevada Dr. Lake Success NY US 11042 11042

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
K000905URETHROTOME 8667.XXX AND 8670.XXXRichard Wolf Medical Instruments Corp.2000-05-12
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#

summary

FDA Review#

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