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 Lamp, Infrared, Therapeutic Heating
510(k) Number K033035
Device Name TLC MODELS ULK-H AND ULT-H INFRARED LAMPS
Applicant
Tlc Marketing, Inc.
11 Dellcastle Ct.
Montgomery Village,,  MD  20886
Applicant Contact ROBERT MAZZAFERRO
Correspondent
Tlc Marketing, Inc.
11 Dellcastle Ct.
Montgomery Village,,  MD  20886
Correspondent Contact ROBERT MAZZAFERRO
Regulation Number890.5500
Classification Product Code
ILY  
Date Received09/29/2003
Decision Date 11/20/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-