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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 K043239
Device Name HEALTHSTAR ELITE
Applicant
HILL LABORATORIES CO.
3 BACTON HILL RD.
P.O. BOX 2028
frazer,  PA  19355
Applicant Contact howard a hill
Correspondent
UNDERWRITERS LABORATORIES, INC.
2600 NW LAKE RD.
camas,  WA  98607 -9526
Correspondent Contact marc m mouser
Regulation Number890.5900
Classification Product Code
ITH  
Date Received11/23/2004
Decision Date 12/22/2004
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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