GAMBRO PLASMAFILTRATION SYSTEM
FDA 510(k) clearance K850621 · decided 1985-05-16
Clearance details
- K-number
- K850621
- Device name
- GAMBRO PLASMAFILTRATION SYSTEM
- Applicant
- Gambro, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-02-15
- Decision date
- 1985-05-16
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- LKN
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Lincolnshire, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.