The following data is part of a premarket notification filed by Medical House Products Limited with the FDA for Auto-safety Injector-2 (asi-2).
| Device ID | K082587 |
| 510k Number | K082587 |
| Device Name: | AUTO-SAFETY INJECTOR-2 (ASI-2) |
| Classification | Introducer, Syringe Needle |
| Applicant | MEDICAL HOUSE PRODUCTS LIMITED 199 NEWHALL ROAD Sheffield, GB S9 2qj |
| Contact | Rose Y Guang |
| Correspondent | Rose Y Guang MEDICAL HOUSE PRODUCTS LIMITED 199 NEWHALL ROAD Sheffield, GB S9 2qj |
| Product Code | KZH |
| CFR Regulation Number | 880.6920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-08 |
| Decision Date | 2008-10-02 |
| Summary: | summary |