The following data is part of a premarket notification filed by Mcgaw, Inc. with the FDA for Tpn Fluid Transfer Set.
| Device ID | K905201 |
| 510k Number | K905201 |
| Device Name: | TPN FLUID TRANSFER SET |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | MCGAW, INC. 2525 MCGAW AVE. P.O. BOX 19791 Irvine, CA 92713 -9791 |
| Contact | John G D'angelo |
| Correspondent | John G D'angelo MCGAW, INC. 2525 MCGAW AVE. P.O. BOX 19791 Irvine, CA 92713 -9791 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-20 |
| Decision Date | 1991-01-02 |