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, Ultraviolet, Dermatological
510(k) Number K896191
Device Name SUNTANNING BED, INC. T12 UVA TANNING LAMPS
Applicant
SUNBRONZE
4510 WOODSON RD.
ST. LOUIS,  MO  63134
Applicant Contact DAN GAUTHIER
Correspondent
SUNBRONZE
4510 WOODSON RD.
ST. LOUIS,  MO  63134
Correspondent Contact DAN GAUTHIER
Regulation Number878.4630
Classification Product Code
FTC  
Date Received10/26/1989
Decision Date 12/27/1989
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
-
-