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 Activator, Ultraviolet, For Polymerization
510(k) Number K001719
Device Name Q-LUX PLASMA 100 LIGHT CURE UNIT
Applicant
Rolence Enterprise Co. , Ltd.
18-3 Lane 231 Pu Chung Rd.
Chungli 320,  TW
Applicant Contact STERLING CHENG
Correspondent
Rolence Enterprise Co. , Ltd.
18-3 Lane 231 Pu Chung Rd.
Chungli 320,  TW
Correspondent Contact STERLING CHENG
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received06/05/2000
Decision Date 10/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-