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 Unit, Syringe, Air And/Or Water
510(k) Number K890290
Device Name BRACE (ORAFIX SPECIAL)
Applicant
Norcliff Thayer, Inc.
303 S. Broadway
Tarrytown,  NY  10591
Applicant Contact ROBERTS, M.D.
Correspondent
Norcliff Thayer, Inc.
303 S. Broadway
Tarrytown,  NY  10591
Correspondent Contact ROBERTS, M.D.
Regulation Number872.4565
Classification Product Code
ECB  
Date Received01/19/1989
Decision Date 03/29/1989
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
-
-