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 |