FDA.report

510(k) K944671

Device
VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID})
Applicant
JEDMED INSTRUMENT CO.
510(k) number
K944671
Product code
EOB  
Decision
Substantially Equivalent (SESE)
Decision date
1995-02-07
Date received
1994-09-22
Regulation
874.4760
Classification name
Nasopharyngoscope (flexible Or Rigid)
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

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

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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