SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER
FDA 510(k) clearance K912920 · decided 1991-09-25
Clearance details
- K-number
- K912920
- Device name
- SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER
- Applicant
- 3M Health Care, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1991-07-03
- Decision date
- 1991-09-25
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- DTZ
- Device class
- 2
- Regulation number
- 870.4350
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Ann Arbor, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.