The following data is part of a premarket notification filed by Douglas Medical Products Corp. with the FDA for Blood Administration Set.
Device ID | K920788 |
510k Number | K920788 |
Device Name: | BLOOD ADMINISTRATION SET |
Classification | Set, Blood Transfusion |
Applicant | DOUGLAS MEDICAL PRODUCTS CORP. 345 DUNBAR RD. Mundelein, IL 60060 |
Contact | Douglas Johnson |
Correspondent | Douglas Johnson DOUGLAS MEDICAL PRODUCTS CORP. 345 DUNBAR RD. Mundelein, IL 60060 |
Product Code | BRZ |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-02-20 |
Decision Date | 1992-06-04 |