R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC)
FDA 510(k) clearance K961610 · decided 1996-07-01
Clearance details
- K-number
- K961610
- Device name
- R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC)
- Applicant
- R&D Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-04-25
- Decision date
- 1996-07-01
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- GKZ
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.