• 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 K872648
Device Name SOLAR GOLD UVA SUN TANNING BED
Applicant
AN-MAR INTERNATIONAL, LTD.
345 EAST BEINORIS DR.
WOOD DALE,  IL  60191
Applicant Contact ANDRZEJ BOBEL
Correspondent
AN-MAR INTERNATIONAL, LTD.
345 EAST BEINORIS DR.
WOOD DALE,  IL  60191
Correspondent Contact ANDRZEJ BOBEL
Regulation Number878.4630
Classification Product Code
FTC  
Date Received07/07/1987
Decision Date 08/04/1987
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
-
-