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 insufflator, laparoscopic
510(k) Number K052125
Device Name CARBONAID GAS DIFFUSER
Applicant
CARDIA INNOVATION AB
7307 GLOCHESTER DRIVE
EDINA,  MN  55435
Applicant Contact JEFFREY R SHIDEMAN
Correspondent
CARDIA INNOVATION AB
7307 GLOCHESTER DRIVE
EDINA,  MN  55435
Correspondent Contact JEFFREY R SHIDEMAN
Regulation Number884.1730
Classification Product Code
HIF  
Date Received08/05/2005
Decision Date 02/08/2006
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
-
-