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 Pump, Infusion, Enteral
510(k) Number K111381
Device Name MEDI-SIS SYRINGE INFUSION SYSTEM
Applicant
Acacia, Inc.
785 Challenger St.
Brea,  CA  92821
Applicant Contact FERGIE FERGUSON
Correspondent
Acacia, Inc.
785 Challenger St.
Brea,  CA  92821
Correspondent Contact FERGIE FERGUSON
Regulation Number880.5725
Classification Product Code
LZH  
Date Received05/17/2011
Decision Date 01/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-