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510(k) K943904

Device
RIGID TELESCOPES
Applicant
KARL STORZ ENDOSKOP GMBH
510(k) number
K943904
Product code
ENZ  
Decision
Substantially Equivalent (SESE)
Decision date
1994-10-14
Date received
1994-08-11
Regulation
874.4680
Classification name
Telescope, Laryngeal-bronchial
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
BETTY M JOHNSON
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 ENZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K944032VIDEO SCOPE SYSTEM (LARYNGOSCOPE)Jedmed Instrument Co.1995-09-15
K790845DUALUME LARYNGEAL EXAMINATION TELESCOPENational Medical Technology1979-07-24

Legacy Summary#

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FDA Review#

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