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 K963682
Device Name GENIE' SINGLE CEILING AND DOUBLE CEILING
Applicant
BURTON MEDICAL PRODUCTS CORP.
21100 LASSEN ST.
CHATSWORTH,  CA  91311
Applicant Contact GRETEL LUMLEY
Correspondent
BURTON MEDICAL PRODUCTS CORP.
21100 LASSEN ST.
CHATSWORTH,  CA  91311
Correspondent Contact GRETEL LUMLEY
Regulation Number878.4580
Classification Product Code
FSY  
Date Received09/03/1996
Decision Date 11/13/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-