POLYSTAN HEART-LUNG MACHINE SYSTEM
FDA 510(k) clearance K894657 · decided 1990-03-28
Clearance details
- K-number
- K894657
- Device name
- POLYSTAN HEART-LUNG MACHINE SYSTEM
- Applicant
- Polystan C/O Vitalcor, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-07-24
- Decision date
- 1990-03-28
- Days to decision
- 247 days
- Clearance type
- Traditional
- Product code
- DJQ
- Device class
- 2
- Regulation number
- 862.3670
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Denmark, DK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.