The following data is part of a premarket notification filed by Shotwell & Carr, Inc. with the FDA for Device, Warming, Blood And Plasma.
Device ID | BK990018 |
510k Number | BK990018 |
Device Name: | Device, Warming, Blood And Plasma |
Classification | Device, Warming. Blood And Plasma |
Applicant | Shotwell & Carr, Inc. 3535 Firewheel Drive suite A Flower Mound, TX 75028 2628 |
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 | 1999-07-08 |
Decision Date | 1999-10-13 |