The following data is part of a premarket notification filed by Flow Laboratories, Inc. with the FDA for Pbs For Fa (46-991-49).
| Device ID | K781391 |
| 510k Number | K781391 |
| Device Name: | PBS FOR FA (46-991-49) |
| Classification | Formulations, Balanced Salt Solutions |
| Applicant | FLOW LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KIP |
| CFR Regulation Number | 864.2875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-10 |
| Decision Date | 1978-08-21 |