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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name equipment, traction, powered
510(k) Number K051013
Device Name SPINEMED S200B/S200C
Applicant
CERT HEALTH SCIENCES, LLC
10440 LITTLE PATUXENT PARKWAY
SUITE 300
COLUMBIA,  MD  21044
Applicant Contact TIM R EMSKY
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 COMMERCE RD.
NEWTON,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number890.5900
Classification Product Code
ITH  
Date Received04/21/2005
Decision Date 04/27/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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