The following data is part of a premarket notification filed by Becton Dickinson Vacutainer Systems with the FDA for Lok-on Needle Disposal System.
Device ID | K951886 |
510k Number | K951886 |
Device Name: | LOK-ON NEEDLE DISPOSAL SYSTEM |
Classification | Tubes, Vacuum Sample, With Anticoagulant |
Applicant | BECTON DICKINSON VACUTAINER SYSTEMS ONE BECTON DR. Franklin Lakes, NJ 07417 -1885 |
Contact | Denise Duchene |
Correspondent | Denise Duchene BECTON DICKINSON VACUTAINER SYSTEMS ONE BECTON DR. Franklin Lakes, NJ 07417 -1885 |
Product Code | GIM |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-24 |
Decision Date | 1995-06-30 |