The following data is part of a premarket notification filed by Pharma-pen, Inc. with the FDA for Confidose Im Auto-injector.
| Device ID | K060389 |
| 510k Number | K060389 |
| Device Name: | CONFIDOSE IM AUTO-INJECTOR |
| Classification | Introducer, Syringe Needle |
| Applicant | PHARMA-PEN, INC. 555 13TH STREET, NW Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahn |
| Correspondent | Jonathan S Kahn PHARMA-PEN, INC. 555 13TH STREET, NW Washington, DC 20004 -1109 |
| Product Code | KZH |
| CFR Regulation Number | 880.6920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-14 |
| Decision Date | 2006-06-06 |
| Summary: | summary |