The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Vacutainer Sst Ii Plus Tubes.
Device ID | K023331 |
510k Number | K023331 |
Device Name: | BD VACUTAINER SST II PLUS TUBES |
Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
Applicant | BECTON DICKINSON & CO. 1 BECTON DRIVE, MC 300 Franklin Lakes, NJ 07417 -1880 |
Contact | Jing Zhang |
Correspondent | Jing Zhang BECTON DICKINSON & CO. 1 BECTON DRIVE, MC 300 Franklin Lakes, NJ 07417 -1880 |
Product Code | JKA |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-10-04 |
Decision Date | 2002-11-25 |
Summary: | summary |