AUTOTRANSFUSION SUCTION SET
FDA 510(k) clearance K920618 · decided 1993-03-12
Clearance details
- K-number
- K920618
- Device name
- AUTOTRANSFUSION SUCTION SET
- Applicant
- Lifestream Int'L, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-02-11
- Decision date
- 1993-03-12
- Days to decision
- 395 days
- Clearance type
- Traditional
- Product code
- CAC
- Device class
- 2
- Regulation number
- 868.5830
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- The Woodlands, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.