The following data is part of a premarket notification filed by Medi-dose, Inc. with the FDA for Chemo-spike Ii Reconstitution Device.
| Device ID | K974431 |
| 510k Number | K974431 |
| Device Name: | CHEMO-SPIKE II RECONSTITUTION DEVICE |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | MEDI-DOSE, INC. 1785 STOUT DR. Warminster, PA 18974 -6101 |
| Contact | Robert Braverman |
| Correspondent | Robert Braverman MEDI-DOSE, INC. 1785 STOUT DR. Warminster, PA 18974 -6101 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-24 |
| Decision Date | 1998-01-08 |
| Summary: | summary |