The following data is part of a premarket notification filed by Medical House (asi) Limited with the FDA for Compact Auto-safety Injector (casi).
| Device ID | K073476 |
| 510k Number | K073476 |
| Device Name: | COMPACT AUTO-SAFETY INJECTOR (CASI) |
| Classification | Introducer, Syringe Needle |
| Applicant | MEDICAL HOUSE (ASI) LIMITED 199, NEWHALL RD. Sheffield, GB S9 2qj |
| Contact | Rose Y Guang |
| Correspondent | Rose Y Guang MEDICAL HOUSE (ASI) LIMITED 199, NEWHALL RD. Sheffield, GB S9 2qj |
| Product Code | KZH |
| CFR Regulation Number | 880.6920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2007-12-10 |
| Decision Date | 2008-03-07 |
| Summary: | summary |