• 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 Booth, Sun Tan
510(k) Number K935854
Device Name ULTRAVIOLET LAMPS FOR TANNING
Applicant
Cosmedico Light, Inc.
333 W. Wacker Dr.
Suite 2600
Chicago,  IL  60606 -1218
Applicant Contact THOMAS J MULDOON
Correspondent
Cosmedico Light, Inc.
333 W. Wacker Dr.
Suite 2600
Chicago,  IL  60606 -1218
Correspondent Contact THOMAS J MULDOON
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received12/08/1993
Decision Date 01/24/1994
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
Predetermined Change
Control Plan Authorized
No
-
-