The following data is part of a premarket notification filed by Dermoequipos S.r.l. with the FDA for Dermotherap Gun.
| Device ID | K062339 |
| 510k Number | K062339 |
| Device Name: | DERMOTHERAP GUN |
| Classification | Introducer, Syringe Needle |
| Applicant | DERMOEQUIPOS S.R.L. MITZPE AVIV INDUSTRIAL PARK 13 M.p. Misgav, IL 20187 |
| Contact | Benny Arazy |
| Correspondent | Benny Arazy DERMOEQUIPOS S.R.L. MITZPE AVIV INDUSTRIAL PARK 13 M.p. Misgav, IL 20187 |
| Product Code | KZH |
| CFR Regulation Number | 880.6920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-10 |
| Decision Date | 2007-02-05 |