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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name source, carrier, fiberoptic light
510(k) Number K896384
Device Name FIBEROPTIC LIGHT SOURCE, FOI-1A
Applicant
JEDMED INSTRUMENT CO.
1430 HANLEY INDUSTRIAL CT.
ST. LOUIS,  MO  63144
Applicant Contact CRAIG RAPP
Correspondent
JEDMED INSTRUMENT CO.
1430 HANLEY INDUSTRIAL CT.
ST. LOUIS,  MO  63144
Correspondent Contact CRAIG RAPP
Regulation Number874.4350
Classification Product Code
EQH  
Date Received11/06/1989
Decision Date 01/23/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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