• 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 device, monitoring, intracranial pressure
510(k) Number K141869
Device Name QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT
Applicant
HEMEDEX INCORPORATED
222 3rd St Suite 0123
CAMBRIDGE,  MA  02142
Applicant Contact DEAN HONKONEN
Correspondent
HEMEDEX INCORPORATED
222 3rd St Suite 0123
CAMBRIDGE,  MA  02142
Correspondent Contact DEAN HONKONEN
Regulation Number882.1620
Classification Product Code
GWM  
Subsequent Product Code
HBG  
Date Received07/11/2014
Decision Date 10/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-