The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Sensicare Synthetic, Surgical Glove Liner.
| Device ID | K950995 |
| 510k Number | K950995 |
| Device Name: | SENSICARE SYNTHETIC, SURGICAL GLOVE LINER |
| Classification | Apparatus, Visual Reinforcement Audiometric |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | Edward Rosen |
| Correspondent | Edward Rosen BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | LYN |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-03 |
| Decision Date | 1995-06-28 |