The following data is part of a premarket notification filed by American Mcgaw with the FDA for Add-a-vial Solution Transfer Device.
| Device ID | K843639 |
| 510k Number | K843639 |
| Device Name: | ADD-A-VIAL SOLUTION TRANSFER DEVICE |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | AMERICAN MCGAW P.O. BOX 1187 Santa Ana, CA 92711 |
| Contact | Floyd Benjamin |
| Correspondent | Floyd Benjamin AMERICAN MCGAW P.O. BOX 1187 Santa Ana, CA 92711 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-17 |
| Decision Date | 1985-01-14 |