510(k) K191174
- Device
- Mercy BabyTAPE
- Applicant
- Children's Mercy Hospital
- 510(k) number
- K191174
- Product code
- PIR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-10-10
- Date received
- 2019-05-01
- Regulation
- 878.4800
- Classification name
- Mercy Tape 2d And 3d Models
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Susan Abdel-Rahman
- Address
- 2401 Gilham Rd. Kansas City MO US 64108 64108
Source Documents#
Other 510(k) Records For Product Code PIR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K142469 | 2D Mercy TAPE & 3D Mercy TAPE | Children'S Mercy Hospital | 2015-05-01 |
Legacy Summary#
summary
FDA Review#
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