510(k) K142469
- Device
- 2D Mercy TAPE & 3D Mercy TAPE
- Applicant
- Children's Mercy Hospital
- 510(k) number
- K142469
- Product code
- PIR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-05-01
- Date received
- 2014-09-03
- 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., Suite 0411 Kansas City MO US 64108 64108
Source Documents#
Other 510(k) Records For Product Code PIR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K191174 | Mercy babyTAPE | Children'S Mercy Hospital | 2019-10-10 |
Legacy Summary#
summary
FDA Review#
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