The following data is part of a premarket notification filed by Level 1 Technologies, Inc. with the FDA for Level 1* Inject Needle-free Injection Site.
| Device ID | K942271 |
| 510k Number | K942271 |
| Device Name: | LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE |
| Classification | Set, Administration, Intravascular |
| Applicant | LEVEL 1 TECHNOLOGIES, INC. 160 WEYMOUTH ST. Rockland, MA 02370 |
| Contact | Nancy Haskins-leblanc |
| Correspondent | Nancy Haskins-leblanc LEVEL 1 TECHNOLOGIES, INC. 160 WEYMOUTH ST. Rockland, MA 02370 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-10 |
| Decision Date | 1995-07-12 |