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 Plier, Orthodontic
510(k) Number K924295
Device Name DEBRACKETING INSTRUMENT
Applicant
Unitek Corp.
2724 S. Peck Rd.
Monrovia,  CA  91016
Applicant Contact MARLYN SCHEFF
Correspondent
Unitek Corp.
2724 S. Peck Rd.
Monrovia,  CA  91016
Correspondent Contact MARLYN SCHEFF
Regulation Number872.4565
Classification Product Code
JEX  
Date Received08/26/1992
Decision Date 11/23/1992
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
-
-