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 (Manual)
510(k) Number K022712
Device Name HAND DRILL, MODEL 11-9901-7
Applicant
Medical Design, LLC
213 Sunset Dr.
Brandon,  SD  57005
Applicant Contact PAUL JOHN AXT
Correspondent
Medical Design, LLC
213 Sunset Dr.
Brandon,  SD  57005
Correspondent Contact PAUL JOHN AXT
Regulation Number882.4300
Classification Product Code
HBG  
Date Received08/14/2002
Decision Date 11/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-