The following data is part of a premarket notification filed by Arbor Technologies, Inc. with the FDA for Microsept 60/20.
Device ID | K890844 |
510k Number | K890844 |
Device Name: | MICROSEPT 60/20 |
Classification | Microfilter, Blood Transfusion |
Applicant | ARBOR TECHNOLOGIES, INC. 3728 PLAZA DR. Ann Arbor, MI 48108 |
Contact | Dawn I Moore |
Correspondent | Dawn I Moore ARBOR TECHNOLOGIES, INC. 3728 PLAZA DR. Ann Arbor, MI 48108 |
Product Code | CAK |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-21 |
Decision Date | 1989-06-07 |