The following data is part of a premarket notification filed by Seabrook Medical Systems, Inc. with the FDA for Device, Warming, Blood And Plasma.
Device ID | BK870011 |
510k Number | BK870011 |
Device Name: | Device, Warming, Blood And Plasma |
Classification | Device, Warming. Blood And Plasma |
Applicant | Seabrook Medical Systems, Inc. 673 Wilmer Aveune Cincinnati, OH 45226 |
Product Code | KZL |
CFR Regulation Number | 864.9205 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-28 |
Decision Date | 1987-09-14 |