The following data is part of a premarket notification filed by Gambro Inc. with the FDA for Device, Heat Sealing.
| Device ID | BK870024 |
| 510k Number | BK870024 |
| Device Name: | Device, Heat Sealing |
| Classification | Device, Heat-sealing |
| Applicant | Gambro Inc. 23872 Kelsey Road Barrington, IL 60010 |
| Product Code | KSD |
| CFR Regulation Number | 864.9750 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-02 |
| Decision Date | 1987-11-02 |