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 Booth, Sun Tan
510(k) Number K944015
Device Name HARPO SUNBED, SUN TANNING MACHINE
Applicant
Harpo Industries
Jufferswegje 12
Jb Kapell
Holland,  NL
Applicant Contact BOB WAGNER
Correspondent
Harpo Industries
Jufferswegje 12
Jb Kapell
Holland,  NL
Correspondent Contact BOB WAGNER
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received08/12/1994
Decision Date 09/06/1994
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
-
-