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 K860370
Device Name SAFE SUN 700 HOME TANNING UNIT
Applicant
SAFE SUN CORPORATION OF AMERICA, INC.
2770 SUMMER ST.
STAMFORD,  CT  06905
Applicant Contact ROBERT L SCHWARTZ
Correspondent
SAFE SUN CORPORATION OF AMERICA, INC.
2770 SUMMER ST.
STAMFORD,  CT  06905
Correspondent Contact ROBERT L SCHWARTZ
Regulation Number878.4630
Classification Product Code
FTC  
Date Received02/03/1986
Decision Date 03/28/1986
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
-
-