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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, surgical, ceiling mounted
510(k) Number K981081
Device Name BRIGHTSTAR
Applicant
HILL-ROM, INC.
1069 STATE ROUTE 46 EAST
BATESVILLE,  IN  47006
Applicant Contact WILLIAM D JORDAN
Correspondent
HILL-ROM, INC.
1069 STATE ROUTE 46 EAST
BATESVILLE,  IN  47006
Correspondent Contact WILLIAM D JORDAN
Regulation Number878.4580
Classification Product Code
FSY  
Date Received03/24/1998
Decision Date 04/29/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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