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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 K133348
FOIA Releasable 510(k) K133348
Device Name STIM PROBE
Applicant
SPES MEDICA S.R.L.
VIA EUROPA-ZONA INDUSTRIALE
BATTIPAGLIA,  IT 84091
Applicant Contact GIORGIO FACCO
Correspondent
SPES MEDICA S.R.L.
VIA EUROPA-ZONA INDUSTRIALE
BATTIPAGLIA,  IT 84091
Correspondent Contact GIORGIO FACCO
Regulation Number874.1820
Classification Product Code
ETN  
Date Received10/30/2013
Decision Date 11/21/2014
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
Recalls CDRH Recalls
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