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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 Pkwy.
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
Predetermined Change
Control Plan Authorized		 No
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