K950995 is an FDA 510(k) clearance for the SENSICARE SYNTHETIC, SURGICAL GLOVE LINER. This device is classified as a Apparatus, Visual Reinforcement Audiometric (Class II - Special Controls, product code LYN).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lake, US). The FDA issued a Cleared decision on June 28, 1995, 117 days after receiving the submission on March 3, 1995.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1050.
| 510(k) Number | K950995 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 1995 |
| Decision Date | June 28, 1995 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | LYN — Apparatus, Visual Reinforcement Audiometric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1050 |