The following data is part of a premarket notification filed by Hemasure, Inc. with the FDA for Microfilter, Blood Transfusion.
Device ID | BK980014 |
510k Number | BK980014 |
Device Name: | Microfilter, Blood Transfusion |
Classification | Microfilter, Blood Transfusion |
Applicant | Hemasure, Inc. 140 Locke Drive Marlborough, MA 01752 |
Product Code | CAK |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-05-18 |
Decision Date | 1999-05-27 |