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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 K030060
Device Name SPINEMED
Applicant
CERT HEALTH SCIENCES, LLC
203 MAIN ST.
PMB 166
FLEMINGTON,  NJ  08822
Applicant Contact LYNETTE HOWARD
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 COMMERCE RD.
NEWTON,  CT  06470
Regulation Number890.5900
Classification Product Code
ITH  
Date Received01/07/2003
Decision Date 02/05/2003
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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