• 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 needle, hypodermic, single lumen
510(k) Number K915409
Device Name INTRAOSSEOUS ACCESS NEEDLE
Applicant
COOK, INC.
925 SOUTH CURRY PIKE
P.O. BOX 489
bloomington,  IN  47402
Applicant Contact april lavender
Correspondent
COOK, INC.
925 SOUTH CURRY PIKE
P.O. BOX 489
bloomington,  IN  47402
Correspondent Contact april lavender
Regulation Number880.5570
Classification Product Code
FMI  
Date Received12/02/1991
Decision Date 03/04/1992
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-