The following data is part of a premarket notification filed by Globe Ent., Inc. with the FDA for Protos 100ml Burette Infusion Set/ Protos 150ml Burette Infusion Set.
Device ID | K972839 |
510k Number | K972839 |
Device Name: | PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET |
Classification | Set, Administration, Intravascular |
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 | FPA |
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 | 1997-12-17 |