DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES— 510(k) K063114
Substantially EquivalentCoeur, Inc.
FDA 510(k) clearance K063114 for DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES, Substantially Equivalent on 2007-02-09. Applicant: Coeur, Inc.. Device class: 2.
Clearance details
- Applicant
- Coeur, Inc.
- Product code
- Code FPK
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Lebanon, TN, US
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More clearances from Coeur, Inc.
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Data sourced from openFDA. This site is unofficial and independent of the FDA.