The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Connecta Monoflo & Multiflo Infusion Connectors.
Device ID | K884463 |
510k Number | K884463 |
Device Name: | CONNECTA MONOFLO & MULTIFLO INFUSION CONNECTORS |
Classification | Stopcock, I.v. Set |
Applicant | OHMEDA MEDICAL 2007 PAN AM CIRCLE Tampa, FL 33702 |
Contact | Jill Phillips |
Correspondent | Jill Phillips OHMEDA MEDICAL 2007 PAN AM CIRCLE Tampa, FL 33702 |
Product Code | FMG |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-10-24 |
Decision Date | 1989-01-09 |