The following data is part of a premarket notification filed by Globe Ent., Inc. with the FDA for Protos I.v. Administration Set (15 Drops/ml) I4070s/(60 Drops/ml)i4670s Preliminary.
| Device ID | K972854 |
| 510k Number | K972854 |
| Device Name: | PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S PRELIMINARY |
| 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 |