The following data is part of a premarket notification filed by Acacia, Inc. with the FDA for Medi-sis Syringe Infusion System.
Device ID | K111381 |
510k Number | K111381 |
Device Name: | MEDI-SIS SYRINGE INFUSION SYSTEM |
Classification | Pump, Infusion, Enteral |
Applicant | ACACIA, INC. 785 CHALLENGER STREET Brea, CA 92821 |
Contact | Fergie Ferguson |
Correspondent | Fergie Ferguson ACACIA, INC. 785 CHALLENGER STREET Brea, CA 92821 |
Product Code | LZH |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-05-17 |
Decision Date | 2012-01-13 |
Summary: | summary |