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 K992090
Device Name MILLENNIUM GOLD
Applicant
SKYTRON, DIV. THE KMW GROUP, INC.
5000 36TH ST., S.E.
GRAND RAPIDS,  MI  49512
Applicant Contact KARI OGREEN
Correspondent
SKYTRON, DIV. THE KMW GROUP, INC.
5000 36TH ST., S.E.
GRAND RAPIDS,  MI  49512
Correspondent Contact KARI OGREEN
Regulation Number878.4580
Classification Product Code
FSY  
Date Received06/21/1999
Decision Date 09/08/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-