PLASMA SEPARATION SYSTEM
FDA premarket approval P820032 · decided 1983-10-07
Approval details
- PMA number
- P820032
- Trade name
- PLASMA SEPARATION SYSTEM
- Generic name
- CERAMICS, CALCIUM TRIPHOSPHATE/HYDROXYPATITE, NON-LOAD BEARING USES
- Applicant
- Fenwal, Inc.
- Date received
- 1982-05-25
- Decision date
- 1983-10-07
- Days to decision
- 500 days
- Decision code
- APWD
- Product code
- LMN
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lake Zurich, IL
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED (K141019) | Fenwal, Inc. | 2014-06-10 |
| AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE (K111702) | Fenwal, Inc. | 2012-03-22 |
| BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR (K073339) | Fenwal, Inc. | 2008-03-03 |