The following data is part of a premarket notification filed by Valmed S.r.l. with the FDA for Eva Tpn Bag.
| Device ID | K101412 |
| 510k Number | K101412 |
| Device Name: | EVA TPN BAG |
| Classification | Container, I.v. |
| Applicant | VALMED S.R.L. VIA PROVINCIALE 10 Mazzo Di Valtellina So, IT I 23030 |
| Contact | Walter Svanosio |
| Correspondent | Walter Svanosio VALMED S.R.L. VIA PROVINCIALE 10 Mazzo Di Valtellina So, IT I 23030 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-20 |
| Decision Date | 2011-04-13 |
| Summary: | summary |