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 Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed
510(k) Number K041978
Device Name REPROCESSED DIAMOND BURS
Applicant
ALLIANCE MEDICAL CORP.
10232 SOUTH 51ST ST.
PHOENIX,  AZ  85044
Applicant Contact ERIC VARTY
Correspondent
ALLIANCE MEDICAL CORP.
10232 SOUTH 51ST ST.
PHOENIX,  AZ  85044
Correspondent Contact ERIC VARTY
Regulation Number882.4310
Classification Product Code
NLN  
Date Received07/23/2004
Decision Date 11/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-