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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electro-Acupuncture
510(k) Number K091875
Device Name E-PULSE
Applicant
MEDEVICE CORPORATION
11 NE 15TH AVE
POMPANO BEACH,  FL  33060
Applicant Contact TZVI MILSHTEIN
Correspondent
MEDEVICE CORPORATION
11 NE 15TH AVE
POMPANO BEACH,  FL  33060
Correspondent Contact TZVI MILSHTEIN
Classification Product Code
BWK  
Date Received06/23/2009
Decision Date 12/07/2009
Decision Substantially Equivalent (SESE)
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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