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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 K811943
Device Name MACHIDA NASOPHARYNGO-LARYNGOSCOPE
Applicant
MACHIDA AMERICA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MACHIDA AMERICA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.4760
Classification Product Code
EQN  
Date Received07/07/1981
Decision Date 07/28/1981
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
Predetermined Change
Control Plan Authorized		 No
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