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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K132616
Device Name EPAD
Applicant
SAFEOP SURGICAL, INC.
125 CHERRY LN.
AMHERST,  MA  01002
Applicant Contact SHEILA HEMEON-HEYER
Correspondent
SAFEOP SURGICAL, INC.
125 CHERRY LN.
AMHERST,  MA  01002
Correspondent Contact SHEILA HEMEON-HEYER
Regulation Number882.1870
Classification Product Code
GWF  
Subsequent Product Codes
GXY   IKN  
Date Received08/21/2013
Decision Date 01/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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