The following data is part of a premarket notification filed by Shl Medical, Usa with the FDA for Shl Disposable Autoinjector.
| Device ID | K050434 |
| 510k Number | K050434 |
| Device Name: | SHL DISPOSABLE AUTOINJECTOR |
| Classification | Introducer, Syringe Needle |
| Applicant | SHL MEDICAL, USA 23 VREELAND RD., SUITE 104 Florham Park, NJ 07932 |
| Contact | Lucio Giambattista |
| Correspondent | Lucio Giambattista SHL MEDICAL, USA 23 VREELAND RD., SUITE 104 Florham Park, NJ 07932 |
| Product Code | KZH |
| CFR Regulation Number | 880.6920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-22 |
| Decision Date | 2005-06-24 |
| Summary: | summary |