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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 K093373
Device Name LARYNGEAL SURFACE ELECTRODE
Applicant
SPES MEDICA S.R.L.
VIA EUROPA-ZONA INDUSTRIALE
BATTIPAGLIA,  IT 84091
Applicant Contact ALFREDO SPADAVECHIA
Correspondent
SPES MEDICA S.R.L.
VIA EUROPA-ZONA INDUSTRIALE
BATTIPAGLIA,  IT 84091
Correspondent Contact ALFREDO SPADAVECHIA
Regulation Number874.1820
Classification Product Code
ETN  
Date Received10/29/2009
Decision Date 08/24/2010
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
Recalls CDRH Recalls
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