The following data is part of a De Novo classification by Moerae Matrix, Inc. with the FDA for Moerae Surgical Marking Pen.
| DeNovo ID | DEN130004 |
| Device Name: | MOERAE SURGICAL MARKING PEN |
| Classification | Internal Tissue Marker |
| Applicant | MOERAE MATRIX, INC. 675 Us Highway 1 North Brunswick, NJ 08902 |
| Contact | Robert J Chin |
| Product Code | PDW |
| CFR Regulation Number | 878.4670 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | General & Plastic Surgery |
| Classification Advisory | General & Plastic Surgery |
| Type | Post-NSE |
| Date Received | 2013-05-06 |
| Decision Date | 2014-12-18 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |