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 K030172
Device Name SMALL HIGH SPEED MOTOR DRILL SYSTEM
Applicant
BRASSELER USA I, L.P.
4837 MCGRATH ST., SUITE J
VENTURA,  CA  93003
Applicant Contact ANTHONY V ROSE
Correspondent
BRASSELER USA I, L.P.
4837 MCGRATH ST., SUITE J
VENTURA,  CA  93003
Correspondent Contact ANTHONY V ROSE
Regulation Number882.4310
Classification Product Code
HBE  
Date Received01/17/2003
Decision Date 04/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-