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 Headgear, Extraoral, Orthodontic
510(k) Number K912682
Device Name ORTHODONTIC HEADGEAR
Applicant
K-Tek Orthodontic Products
29 Scenic Dr.
Ashland,  OR  97520
Applicant Contact LINDA KATZEN
Correspondent
K-Tek Orthodontic Products
29 Scenic Dr.
Ashland,  OR  97520
Correspondent Contact LINDA KATZEN
Regulation Number872.5500
Classification Product Code
DZB  
Date Received06/13/1991
Decision Date 12/09/1991
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
-
-