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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.
St. Louis,  MO  63129 -2221
Applicant Contact CRAIG PARKS
Correspondent
Jedmed Instrument Co.
5416 Jedmed Ct.
St. Louis,  MO  63129 -2221
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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