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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, nerve
510(k) Number K091874
Device Name INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656
Applicant
INOMED MEDIZINTECHNIK GMBH
1468 HARWELL AVE
CROFTON,  MD  21114
Applicant Contact YOLANDA SMITH
Correspondent
INOMED MEDIZINTECHNIK GMBH
1468 HARWELL AVE
CROFTON,  MD  21114
Correspondent Contact YOLANDA SMITH
Regulation Number874.1820
Classification Product Code
ETN  
Date Received06/23/2009
Decision Date 11/18/2009
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
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