The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Empty Containers For The Collection & Processing Of Blood/blood Components.
Device ID | BK970027 |
510k Number | BK970027 |
Device Name: | Empty Containers For The Collection & Processing Of Blood/Blood Components |
Classification | Container, Empty, For Collection & Processing Of Blood & Blood Components |
Applicant | Utah Medical Products, Inc. 7043 South 300 West Midvale, UT 84047 US |
Product Code | KSR |
CFR Regulation Number | 864.9100 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-07-28 |
Decision Date | 1998-01-06 |