The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Vasculon 2 Intravenous Cannula.
Device ID | K883415 |
510k Number | K883415 |
Device Name: | VASCULON 2 INTRAVENOUS CANNULA |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
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 | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-15 |
Decision Date | 1988-10-04 |