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 K861963
Device Name ULTRALITE HF1236 HAND AND FOOT SYSTEM
Applicant
Ultralite
390 Farmer Ct.
Lawrenceville,  GA  30245
Applicant Contact WILLIAM C MCMILLAN
Correspondent
Ultralite
390 Farmer Ct.
Lawrenceville,  GA  30245
Correspondent Contact WILLIAM C MCMILLAN
Regulation Number878.4630
Classification Product Code
FTC  
Date Received05/20/1986
Decision Date 06/25/1986
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
Predetermined Change
Control Plan Authorized		 No
-
-