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 & accessories (simple, powered)
510(k) Number K984035
Device Name XK-95 HIGH SPEED MOTOR DRILL SYSTEM
Applicant
KOMET MEDICAL
1679 KELLOGG SPRINGS DR.
ATLANTA,  GA  30338
Applicant Contact COURTNEY S PARADICE
Correspondent
KOMET MEDICAL
1679 KELLOGG SPRINGS DR.
ATLANTA,  GA  30338
Correspondent Contact COURTNEY S PARADICE
Regulation Number882.4310
Classification Product Code
HBE  
Date Received11/12/1998
Decision Date 06/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-