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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 K132039
Device Name ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM
Applicant
Jedmed Instrument Co.
5416 Jedmed Ct.
Saint Louis,  MO  63129
Applicant Contact CRAIG PARKS
Correspondent
Jedmed Instrument Co.
5416 Jedmed Ct.
Saint Louis,  MO  63129
Correspondent Contact CRAIG PARKS
Regulation Number874.4760
Classification Product Code
EQN  
Date Received07/02/2013
Decision Date 02/21/2014
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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