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510(k) K944032

Device
VIDEO SCOPE SYSTEM (LARYNGOSCOPE)
Applicant
JEDMED INSTRUMENT CO.
510(k) number
K944032
Product code
ENZ  
Decision
Substantially Equivalent (SESE)
Decision date
1995-09-15
Date received
1994-08-17
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
CRAIG R PARKS
Address
6096 Lemay Ferry Rd. St.Louis MO US 63129 63129

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
K943904RIGID TELESCOPESKarl Storz Endoskop GmbH1994-10-14
K790845DUALUME LARYNGEAL EXAMINATION TELESCOPENational Medical Technology1979-07-24

Legacy Summary#

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FDA Review#

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