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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cuff, Nerve
510(k) Number K100382
Device Name SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331
Applicant
Salumedica, LLC
931 E Ponce De Leon Ave.
Atlanta,  GA  30306
Applicant Contact BOB BRADEN
Correspondent
Salumedica, LLC
931 E Ponce De Leon Ave.
Atlanta,  GA  30306
Correspondent Contact BOB BRADEN
Regulation Number882.5275
Classification Product Code
JXI  
Date Received02/16/2010
Decision Date 08/05/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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