MINI-OP ATS BLOOD RECOVERY BAG, MODEL 2955
FDA 510(k) clearance K912610 · decided 1991-11-29
Clearance details
- K-number
- K912610
- Device name
- MINI-OP ATS BLOOD RECOVERY BAG, MODEL 2955
- Applicant
- Atrium Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-06-12
- Decision date
- 1991-11-29
- Days to decision
- 170 days
- Clearance type
- Traditional
- Product code
- CAC
- Device class
- 2
- Regulation number
- 868.5830
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Hollis, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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