The following data is part of a premarket notification filed by M.v. S.r.l. with the FDA for Mv Intradermic Needles; Magic Needle; Magic Needle.
| Device ID | K110606 |
| 510k Number | K110606 |
| Device Name: | MV INTRADERMIC NEEDLES; MAGIC NEEDLE; MAGIC NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | M.V. S.R.L. VIA MARZIA 9 Abano Terme Padova, IT 35031 |
| Contact | Enrico Bisson |
| Correspondent | Enrico Bisson M.V. S.R.L. VIA MARZIA 9 Abano Terme Padova, IT 35031 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-03 |
| Decision Date | 2011-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760264550235 | K110606 | 000 |
| 03760264550228 | K110606 | 000 |
| 03760264550211 | K110606 | 000 |
| 03760264550204 | K110606 | 000 |
| 03760264550198 | K110606 | 000 |
| 03760264550181 | K110606 | 000 |
| 03760264550174 | K110606 | 000 |
| 03760264550013 | K110606 | 000 |