• 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 K854750
Device Name TOP SUN
Applicant
WERNER SCHOTT ELEKTROGERATE
POSTFACH 1660 AM PFERDEMAK7 TI
3012 LANGENHAGEN 1
WEST GERMANY,  DE
Applicant Contact UNGRUH GMBLT
Correspondent
WERNER SCHOTT ELEKTROGERATE
POSTFACH 1660 AM PFERDEMAK7 TI
3012 LANGENHAGEN 1
WEST GERMANY,  DE
Correspondent Contact UNGRUH GMBLT
Regulation Number878.4630
Classification Product Code
FTC  
Date Received11/26/1985
Decision Date 02/14/1986
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
-
-