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 Cannula, Manipulator/Injector, Uterine
510(k) Number K153092
Device Name Ally Uterine Positioning System
Applicant
CooperSurgical, Inc.
95 Corporate Dr.
Trumbull,  CT  06611
Applicant Contact Roaida Johnson
Correspondent
CooperSurgical, Inc.
95 Corporate Dr.
Trumbull,  CT  06611
Correspondent Contact Roaida Johnson
Regulation Number884.4530
Classification Product Code
LKF  
Date Received10/26/2015
Decision Date 12/21/2015
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
Predetermined Change
Control Plan Authorized		 No
-
-