COBE CENTRY(R) TPE SYSTEM
FDA premarket approval P810023/S002 · decided 1994-07-05
Approval details
- PMA number
- P810023
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COBE CENTRY(R) TPE SYSTEM
- Generic name
- Separator, automated, blood cell and plasma, therapeutic
- Applicant
- Gambro Bct, Inc.
- Date received
- 1993-04-19
- Decision date
- 1994-07-05
- Days to decision
- 442 days
- Decision code
- APPR
- Product code
- LKN
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Lakewood, CO
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200 (K071079) | Gambro Bct, Inc. | 2007-08-02 |