The following data is part of a premarket notification filed by Globe Ent., Inc. with the FDA for Protos Blood Transfusion Set.
Device ID | K972843 |
510k Number | K972843 |
Device Name: | PROTOS BLOOD TRANSFUSION SET |
Classification | Set, Blood Transfusion |
Applicant | GLOBE ENT., INC. 4930 CAMPBELL RD. Houston, TX 77041 |
Contact | Stephen Y Jan |
Correspondent | Stephen Y Jan GLOBE ENT., INC. 4930 CAMPBELL RD. Houston, TX 77041 |
Product Code | BRZ |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-01 |
Decision Date | 1997-12-16 |