Mercy babyTAPE— 510(k) K191174
Substantially EquivalentChildren'S Mercy Hospital
FDA 510(k) clearance K191174 for Mercy babyTAPE, Substantially Equivalent on 2019-10-10. Applicant: Children'S Mercy Hospital. Device class: 1.
Clearance details
- Applicant
- Children'S Mercy Hospital
- Product code
- Code PIR
- Device class
- Class 1
- Regulation
- 21 CFR 878.4800
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kansas City, MO, US
Recent devices under product code PIR
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