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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, transcutaneous, for arthritis
510(k) Number K111557
Device Name X-FORCE
Original Applicant
SEVEN SEAS DISTRIBTION AND MANUFACTURING LLC
2620 s maryland pkwy
ste 14 unit 835
las vegas,  NV  89109
Original Contact mark ioele
Regulation Number882.5890
Classification Product Code
NYN  
Date Received06/03/2011
Decision Date 11/10/2011
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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