The following data is part of a premarket notification filed by Scandinavian Health Ltd. with the FDA for Pen-inject 2.25.
| Device ID | K954729 |
| 510k Number | K954729 |
| Device Name: | PEN-INJECT 2.25 |
| Classification | Introducer, Syringe Needle |
| Applicant | SCANDINAVIAN HEALTH LTD. 700 THIRTEEENTH STREET, N.W. SUITE 1200 Washington, DC 20005 |
| Contact | Thomas Scarlett |
| Correspondent | Thomas Scarlett SCANDINAVIAN HEALTH LTD. 700 THIRTEEENTH STREET, N.W. SUITE 1200 Washington, DC 20005 |
| Product Code | KZH |
| CFR Regulation Number | 880.6920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-13 |
| Decision Date | 1996-01-29 |