Espire Elbow Pro, Espire Elbow Hybrid— 510(k) K182757
Substantially EquivalentCollege Park Industries, Inc.
FDA 510(k) clearance K182757 for Espire Elbow Pro, Espire Elbow Hybrid, Substantially Equivalent on 2018-11-29. Applicant: College Park Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- College Park Industries, Inc.
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warren, MI, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.