• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name device, neurovascular embolization
510(k) Number K120686
Device Name ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
Original Applicant
Codman & Shurtleff, Inc.
325 paramount dr.
raynham,  MA  02767 -0350
Original Contact kim fonda
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received03/06/2012
Decision Date 04/04/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-