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 K904425
Device Name MODEL 6/01 UV-B FIXTURE
Applicant
Strato-Ray Co.
6500 Walker St.
Minneapolis,  MN  55426
Applicant Contact DONALD GUSTAFSON
Correspondent
Strato-Ray Co.
6500 Walker St.
Minneapolis,  MN  55426
Correspondent Contact DONALD GUSTAFSON
Regulation Number878.4630
Classification Product Code
FTC  
Date Received09/27/1990
Decision Date 11/21/1990
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
-
-