DEXTRAN HM 32
FDA premarket approval P880028/S001 · decided 1989-12-29
Approval details
- PMA number
- P880028
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DEXTRAN HM 32
- Generic name
- FLUID, HYSTEROSCOPY
- Applicant
- Hospira, Inc.
- Date received
- 1989-07-24
- Decision date
- 1989-12-29
- Days to decision
- 158 days
- Decision code
- APPR
- Product code
- LTA
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Lake Forest, IL
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module (K161469) | Hospira, Inc. | 2017-03-28 |
| Hospira Extension Set, Hospira Primary Set (K161036) | Hospira, Inc. | 2017-01-06 |
| Hospira Sapphire Sets (K160492) | Hospira, Inc. | 2016-12-06 |
| Hospira Administration Sets (K160870) | Hospira, Inc. | 2016-06-01 |
| LifeCare PCA Infusion System (K143612) | Hospira, Inc. | 2016-04-08 |
| Hospira Blood Set (K143087) | Hospira, Inc. | 2015-03-04 |
| Hospira Primary Sets (K143015) | Hospira, Inc. | 2015-02-25 |
| PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE (K141789) | Hospira, Inc. | 2015-01-16 |