The following data is part of a premarket notification filed by Chartermed, Inc. with the FDA for Chartermed Empty Tpn Container - 100 Ml Capacity.
| Device ID | K902464 |
| 510k Number | K902464 |
| Device Name: | CHARTERMED EMPTY TPN CONTAINER - 100 ML CAPACITY |
| Classification | Container, I.v. |
| Applicant | CHARTERMED, INC. 70 OBERLIN AVENUE NORTH Lakewood, NJ 08701 |
| Contact | Alice Preville |
| Correspondent | Alice Preville CHARTERMED, INC. 70 OBERLIN AVENUE NORTH 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 | 1990-06-04 |
| Decision Date | 1990-08-30 |