Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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, assisted reproduction
510(k) Number K141365
Device Name OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN
Applicant
WILLIAM A. COOK AUSTRALIA PTY, LTD.
95 BRANDL ST
EIGHT MILE PLAINS, QUEENSLAND,  AU 4113
Applicant Contact KATIE-LOU BUSCHER
Correspondent
WILLIAM A. COOK AUSTRALIA PTY, LTD.
95 BRANDL ST
EIGHT MILE PLAINS, QUEENSLAND,  AU 4113
Correspondent Contact KATIE-LOU BUSCHER
Regulation Number884.6100
Classification Product Code
MQE  
Date Received05/23/2014
Decision Date 08/07/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-