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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laryngoscope, Nasopharyngoscope
510(k) Number K150248
Device Name ORL Video NasoPharyngo-Larngoscope
Applicant
JEDMED INSTRUMENT COMPANY
5416 JEDMED COURT
ST. LOUIS,  MO  63129
Applicant Contact CRAIG PARKS
Correspondent
JEDMED INSTRUMENT COMPANY
5416 JEDMED COURT
ST. LOUIS,  MO  63129
Correspondent Contact CRAIG PARKS
Regulation Number874.4760
Classification Product Code
EQN  
Date Received02/03/2015
Decision Date 07/23/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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