The following data is part of a premarket notification filed by Narang Medical Usa Corporation with the FDA for Nmuc Brand Small And Large Fragment Osteosynthesis Plating System, Nmuc Brand Of Dhs/dcs Plating System.
| Device ID | K163425 |
| 510k Number | K163425 |
| Device Name: | NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand Of DHS/DCS Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | NARANG MEDICAL USA CORPORATION 15951 SW 41 ST SUITE 800B Davie, FL 33331 |
| Contact | Reginald Swift |
| Correspondent | Reginald Swift NARANG MEDICAL USA CORPORATION 15951 SW 41 ST SUITE 800b Davie, FL 33331 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-06 |
| Decision Date | 2017-03-24 |
| Summary: | summary |