• 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 instrument, biopsy, mechanical, gastrointestinal
510(k) Number K070759
Device Name POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM
Applicant
VIDACARE CORPORATION
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Applicant Contact GRACE HOLLAND
Correspondent
VIDACARE CORPORATION
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Correspondent Contact GRACE HOLLAND
Regulation Number876.1075
Classification Product Code
FCF  
Date Received03/20/2007
Decision Date 05/21/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-