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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 K071347
Device Name VAX-D GENESIS G2 SYSTEM
Applicant
VAX-D MEDICAL TECHNOLOGIES LLC
310 MEARS BLVD
OLDSMAR,  FL  34677
Applicant Contact LAWRENCE DYER
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Regulation Number890.5900
Classification Product Code
ITH  
Date Received05/14/2007
Decision Date 10/05/2007
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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