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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, neuromuscular, external functional
510(k) Number K102115
Device Name ODFS PACE
Applicant
ODSTOCK MEDICAL LTD
SALISBURY DISTRICT HOSPITAL
SALISBURY, WILTSHIRE,  GB SP2 8BJ
Applicant Contact STEVEN CROOK
Correspondent
ODSTOCK MEDICAL LTD
SALISBURY DISTRICT HOSPITAL
SALISBURY, WILTSHIRE,  GB SP2 8BJ
Correspondent Contact STEVEN CROOK
Regulation Number882.5810
Classification Product Code
GZI  
Date Received07/28/2010
Decision Date 03/30/2011
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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