CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT
FDA 510(k) clearance K972867 · decided 1997-10-24
Clearance details
- K-number
- K972867
- Device name
- CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT
- Applicant
- Rocket Medical Plc
- Decision
- Substantially Equivalent
- Date received
- 1997-08-04
- Decision date
- 1997-10-24
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- ICX
- Device class
- 1
- Regulation number
- 864.1850
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Washington, Tyne & Wear, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.