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510(k) K945686

Device
KARL STORZ KNIVES, CURETTES
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
510(k) number
K945686
Product code
EZO  
Decision
Substantially Equivalent (SESE)
Decision date
1995-02-13
Date received
1994-11-21
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
JUDITH K MURPHY
Address
600 Corporate Pt.e Culver City CA US 90230 90230

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
K950719OES UROLOGYOlympus America, Inc.1996-12-11
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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