SHILEY 3L CARDIOTOMY RESERVOIR— 510(k) K853503
Substantially EquivalentShiley, Inc.
FDA 510(k) clearance K853503 for SHILEY 3L CARDIOTOMY RESERVOIR, Substantially Equivalent on 1985-11-14. Applicant: Shiley, Inc.. Device class: 2.
Clearance details
- Applicant
- Shiley, Inc.
- Product code
- Code DTP
- Device class
- Class 2
- Regulation
- 21 CFR 870.4230
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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More clearances from Shiley, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.