The following data is part of a premarket notification filed by North American Technical Services Corp. with the FDA for Blood And Plasma Warming Devices.
Device ID | BK910028 |
510k Number | BK910028 |
Device Name: | Blood And Plasma Warming Devices |
Classification | Device, Warming. Blood And Plasma |
Applicant | North American Technical Services Corp. 407 E Main St. Port Jefferson, NY 11777 |
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 | 1991-09-13 |
Decision Date | 1992-07-13 |