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 Burnisher, Operative
510(k) Number K935217
Device Name LC DENTAL HAND INSTRUMENT
Applicant
L.C. Dental
503-A Vandell Way
Campbell,  CA  95008
Applicant Contact LARS CALLNE
Correspondent
L.C. Dental
503-A Vandell Way
Campbell,  CA  95008
Correspondent Contact LARS CALLNE
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received10/26/1993
Decision Date 01/05/1994
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
-
-