The following data is part of a premarket notification filed by Dupaco with the FDA for Device, Warming, Blood And Plasma.
Device ID | BK950038 |
510k Number | BK950038 |
Device Name: | Device, Warming, Blood And Plasma |
Classification | Device, Warming. Blood And Plasma |
Applicant | DUPACO 2620 Temple Heights Dr. Oceanside, CA 92056 |
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 | 1995-08-08 |
Decision Date | 1995-09-01 |