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 intrauterine tamponade balloon
510(k) Number K150573
Device Name ebb Complete Tamponade System
Applicant
CLINICAL INNOVATIONS, LLC
747 WEST 4170 SOUTH
MURRAY,  UT  84123
Applicant Contact Tom Haueter
Correspondent
CLINICAL INNOVATIONS, LLC
747 WEST 4170 SOUTH
MURRAY,  UT  84123
Correspondent Contact Tom Haueter
Regulation Number884.4530
Classification Product Code
OQY  
Date Received03/06/2015
Decision Date 03/25/2015
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
Recalls CDRH Recalls
-
-