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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
Predetermined Change
Control Plan Authorized		 No
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