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 K082731
Device Name ML24000 UVA-1 PHOTOTHERAPY CABINET
Applicant
DAAVLIN DISTRIBUTING CO.
205 WEST BEMENT ST.
BRYAN,  OH  43506
Applicant Contact TARA MANSUR
Correspondent
DAAVLIN DISTRIBUTING CO.
205 WEST BEMENT ST.
BRYAN,  OH  43506
Correspondent Contact TARA MANSUR
Regulation Number878.4630
Classification Product Code
FTC  
Date Received09/18/2008
Decision Date 12/17/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-