510(k) DEN150038
- Device
- CleanCisionTM Wound Retraction and Protection System
- Applicant
- Prescient Surgical
- 510(k) number
- DEN150038
- Product code
- PQI
- Decision
- Unknown (DENG)
- Decision date
- 2016-12-16
- Date received
- 2015-08-13
- Regulation
- 878.4371
- Classification name
- Wound Retraction And Protection System
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Lisa Ruehlow
- Address
- 1585 Industrial Rd. San Carlos CA US 94070 94070
FDA Registration Numbers#
- 2031093
- 2024311
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PQI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172132 | CleanCision Wound Retraction and Protection System | Prescient Surgical, Inc. | 2017-10-25 |