The following data is part of a premarket notification filed by Scandinavian Health Limited with the FDA for Lobster Auto-injector.
| Device ID | K124026 |
| 510k Number | K124026 |
| Device Name: | LOBSTER AUTO-INJECTOR |
| Classification | Introducer, Syringe Needle |
| Applicant | SCANDINAVIAN HEALTH LIMITED #588 JIM MORAN BLVD Deerfield Beach, FL 33442 |
| Contact | James Haynes |
| Correspondent | James Haynes SCANDINAVIAN HEALTH LIMITED #588 JIM MORAN BLVD Deerfield Beach, FL 33442 |
| Product Code | KZH |
| CFR Regulation Number | 880.6920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-28 |
| Decision Date | 2013-09-13 |
| Summary: | summary |