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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 K042482
Device Name BASS ANTALGIC-TRAK
Applicant
TRACTION MASTERS, L.L.C.
9737 NW 65TH WAY
PARKLAND,  FL  33076
Applicant Contact DAVID B BASS
Correspondent
TRACTION MASTERS, L.L.C.
9737 NW 65TH WAY
PARKLAND,  FL  33076
Correspondent Contact DAVID B BASS
Regulation Number890.5900
Classification Product Code
ITH  
Date Received09/13/2004
Decision Date 03/21/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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