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 cabinet, phototherapy (puva)
510(k) Number K841795
Device Name UV 8001K, PUVA 800, PUVA 180/200 1000
Applicant
WALDMANN LIGHTING CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
WALDMANN LIGHTING CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4630
Classification Product Code
KGL  
Date Received05/02/1984
Decision Date 08/30/1984
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
-
-