The following data is part of a premarket notification filed by Becton Dickinson Vacutainer Systems with the FDA for Vacutainer Brand Ctad Tube (multiple).
Device ID | K991120 |
510k Number | K991120 |
Device Name: | VACUTAINER BRAND CTAD TUBE (MULTIPLE) |
Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
Applicant | BECTON DICKINSON VACUTAINER SYSTEMS 1 BECTON DR. Franklin Lakes, NJ 07417 -1885 |
Contact | James W Haynes |
Correspondent | James W Haynes BECTON DICKINSON VACUTAINER SYSTEMS 1 BECTON DR. Franklin Lakes, NJ 07417 -1885 |
Product Code | JKA |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-04-02 |
Decision Date | 1999-05-19 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50382903679473 | K991120 | 000 |