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 Retainer, Screw Expansion, Orthodontic
510(k) Number K843705
Device Name MANDIBULATOR JAW POSITIONER
Applicant
A Company, Inc.
P.O. Box 81247
San Diego,  CA  92138
Applicant Contact JOE MONFREDO
Correspondent
A Company, Inc.
P.O. Box 81247
San Diego,  CA  92138
Correspondent Contact JOE MONFREDO
Regulation Number872.5410
Classification Product Code
DYJ  
Date Received09/21/1984
Decision Date 11/14/1984
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
-
-