The following data is part of a premarket notification filed by Chartermed, Inc. with the FDA for Chartermed Tpn-eva Bags.
| Device ID | K973103 |
| 510k Number | K973103 |
| Device Name: | CHARTERMED TPN-EVA BAGS |
| Classification | Container, I.v. |
| Applicant | CHARTERMED, INC. 1805 SWARTHMORE AVE. Lakewood, NJ 08701 |
| Contact | K. Alice Preville |
| Correspondent | K. Alice Preville CHARTERMED, INC. 1805 SWARTHMORE AVE. Lakewood, NJ 08701 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-19 |
| Decision Date | 1997-11-24 |
| Summary: | summary |