The following data is part of a premarket notification filed by Smith & Nephew, Mpl Division with the FDA for Solopak Brand Filter Needle W/5 Micro.
| Device ID | K841280 |
| 510k Number | K841280 |
| Device Name: | SOLOPAK BRAND FILTER NEEDLE W/5 MICRO |
| Classification | Filter, Infusion Line |
| Applicant | SMITH & NEPHEW, MPL DIVISION 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FPB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-28 |
| Decision Date | 1984-05-21 |