The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Safe Needle Direct Blood Transfer Device, Model Ta-stv.
Device ID | K974374 |
510k Number | K974374 |
Device Name: | SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV |
Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
Applicant | OHMEDA MEDICAL 100 MOUNTAIN AVE. Murray Hill, NJ 07974 -2005 |
Contact | Jing Zhang |
Correspondent | Jing Zhang OHMEDA MEDICAL 100 MOUNTAIN AVE. Murray Hill, NJ 07974 -2005 |
Product Code | JKA |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-11-20 |
Decision Date | 1998-01-02 |
Summary: | summary |