• 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 cannula, manipulator/injector, uterine
510(k) Number K143415
Device Name Air Bubble Based Infuser (ABBI)
Applicant
CooperSurgical, Inc
95 Corporate Dr.
Trumbull,  CT  06611
Applicant Contact James Keller
Correspondent
Regulatory Compliance Associates, Inc.
10411 Corporate Drive, Suite 102
Pleasant Prairie,  WI  53158
Correspondent Contact Chris Henza
Regulation Number884.4530
Classification Product Code
LKF  
Date Received11/28/2014
Decision Date 02/26/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-