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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
Predetermined Change
Control Plan Authorized		 No
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