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 Bit, Drill
510(k) Number K930339
Device Name REAMER BIT
Applicant
Neoligaments, Ltd.
28-30 Blenheim Ter.
Leeds,  GB LS2-9HD
Applicant Contact ROWLAND
Correspondent
Neoligaments, Ltd.
28-30 Blenheim Ter.
Leeds,  GB LS2-9HD
Correspondent Contact ROWLAND
Regulation Number888.4540
Classification Product Code
HTW  
Date Received01/25/1993
Decision Date 08/06/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-