510(k) DEN130004
- Device
- MOERAE SURGICAL MARKING PEN
- Applicant
- Moerae Matrix, Inc.
- 510(k) number
- DEN130004
- Product code
- PDW
- Decision
- Unknown (DENG)
- Decision date
- 2014-12-18
- Date received
- 2013-05-06
- Regulation
- 878.4670
- Classification name
- Internal Tissue Marker
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- ROBERT J CHIN
- Address
- 675 Us Hwy. 1 North Brunswick NJ US 08902 08902
Source Documents#
510(k) summary PDF not indicated by FDA