The following data is part of a premarket notification filed by Douglas Medical Products Corp. with the FDA for 40 Micron Blood Transfusion Filter.
Device ID | K941628 |
510k Number | K941628 |
Device Name: | 40 MICRON BLOOD TRANSFUSION FILTER |
Classification | Filter, Infusion Line |
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 | FPB |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-04 |
Decision Date | 1995-02-16 |