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 Lock, Wire, And Ligature, Intraoral
510(k) Number K910090
Device Name DIMAC WIRES
Applicant
Instrumentations Unltd.
108 James St.
P.O. Box 14
Quakertown,  PA  18951
Applicant Contact CHARLES KAUFFMAN
Correspondent
Instrumentations Unltd.
108 James St.
P.O. Box 14
Quakertown,  PA  18951
Correspondent Contact CHARLES KAUFFMAN
Regulation Number872.4600
Classification Product Code
DYX  
Date Received01/09/1991
Decision Date 07/25/1991
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
-
-