• 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 neurological stereotaxic instrument
510(k) Number K991267
Device Name SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A
Applicant
OHIO MEDICAL INSTRUMENT CO., INC.
4900 CHARLEMAR DR.
CINCINNATI,  OH  45227
Applicant Contact KENNETH B MILLER
Correspondent
OHIO MEDICAL INSTRUMENT CO., INC.
4900 CHARLEMAR DR.
CINCINNATI,  OH  45227
Correspondent Contact KENNETH B MILLER
Regulation Number882.4560
Classification Product Code
HAW  
Date Received04/13/1999
Decision Date 07/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-