Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Light, Surgical, Ceiling Mounted
510(k) Number K981081
Device Name BRIGHTSTAR
Applicant
Hill-Rom, Inc.
1069 State Rte. 46 E.
Batesville,  IN  47006
Applicant Contact WILLIAM D JORDAN
Correspondent
Hill-Rom, Inc.
1069 State Rte. 46 E.
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
Predetermined Change
Control Plan Authorized		 No
-
-