• 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 neurosurgical paddie
510(k) Number K844594
Device Name NEURO CUSTOM SURGICAL KIT
Applicant
XANMED CORP.
815 CONNECTICUT AVENUE NW
WASHINGTON,  DC  20006 -
Applicant Contact DAVID B VANCE
Correspondent
XANMED CORP.
815 CONNECTICUT AVENUE NW
WASHINGTON,  DC  20006 -
Correspondent Contact DAVID B VANCE
Regulation Number882.4700
Classification Product Code
HBA  
Date Received11/26/1984
Decision Date 06/13/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-