COMPLETE CONTROL System Gen2— 510(k) K191083
Substantially EquivalentCoapt, LLC
FDA 510(k) clearance K191083 for COMPLETE CONTROL System Gen2, Substantially Equivalent on 2019-05-24. Applicant: Coapt, LLC. Device class: 2.
Clearance details
- Applicant
- Coapt, LLC
- 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
- Special
- Location
- Chicago, IL, US
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More clearances from Coapt, LLC
view allData sourced from openFDA. This site is unofficial and independent of the FDA.