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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
Applicant
SEVEN SEAS DISTRIBTION AND MANUFACTURING LLC
2620 S MARYLAND PKWY
STE 14 UNIT 835
LAS VEGAS,  NV  89109
Applicant Contact MARK IOELE
Correspondent
SEVEN SEAS DISTRIBTION AND MANUFACTURING LLC
2620 S MARYLAND PKWY
STE 14 UNIT 835
LAS VEGAS,  NV  89109
Correspondent 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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