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 Anesthesia Conduction Kit
510(k) Number K092657
Device Name EPIFUSE CATHETER CONNECTOR, MODEL: 4909E
Applicant
Smiths Medical Asd, Inc.
10 Bowman Dr.
Keene,  NH  03431
Applicant Contact CINDY ENGELHARDT
Correspondent
Smiths Medical Asd, Inc.
10 Bowman Dr.
Keene,  NH  03431
Correspondent Contact CINDY ENGELHARDT
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received08/28/2009
Decision Date 11/04/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-