The following data is part of a premarket notification filed by Concord/portex with the FDA for Safety Needle Sheath.
| Device ID | K904198 |
| 510k Number | K904198 |
| Device Name: | SAFETY NEEDLE SHEATH |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
| Contact | Robert Wheeler |
| Correspondent | Robert Wheeler CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-12 |
| Decision Date | 1990-12-19 |