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 K014060
Device Name MICROAIRE 1000E SYSTEM
Applicant
Microaire Surgical Instruments, Inc.
1641 Edlich Dr.
Charlottesville,  VA  22911
Applicant Contact CARL ANGLES
Correspondent
Microaire Surgical Instruments, Inc.
1641 Edlich Dr.
Charlottesville,  VA  22911
Correspondent Contact CARL ANGLES
Regulation Number882.4310
Classification Product Code
HBE  
Date Received12/10/2001
Decision Date 03/05/2002
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
-
-