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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, transcutaneous, over-the-counter
510(k) Number K132993
Device Name COUNTER OTC TENS DEVICE
Applicant
COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD.
11820 RED HIBISCUS DRIVE
BONITA SPRINGS,  FL  34135
Applicant Contact GUENTER GINSBERG
Correspondent
COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD.
11820 RED HIBISCUS DRIVE
BONITA SPRINGS,  FL  34135
Correspondent Contact GUENTER GINSBERG
Regulation Number882.5890
Classification Product Code
NUH  
Date Received09/24/2013
Decision Date 04/24/2014
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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