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510(k) K790845

Device
DUALUME LARYNGEAL EXAMINATION TELESCOPE
Applicant
NATIONAL MEDICAL TECHNOLOGY
510(k) number
K790845
Product code
ENZ  
Decision
Substantially Equivalent (SESE)
Decision date
1979-07-24
Date received
1979-05-04
Regulation
874.4680
Classification name
Telescope, Laryngeal-bronchial
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K943904RIGID TELESCOPESKarl Storz Endoskop GmbH1994-10-14

Legacy Summary#

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FDA Review#

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