The following data is part of a premarket notification filed by Narang Medical Limited with the FDA for Net Brand Small Fragment And Large Fragment Osteosynthesis Plating System, Net Brand Of Dhs/dcs Plating System.
| Device ID | K150561 |
| 510k Number | K150561 |
| Device Name: | NET Brand Small Fragment And Large Fragment Osteosynthesis Plating System, NET Brand Of DHS/DCS Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | Narang Medical Limited 46, Naraina Industriall Area, Phase 1, New Delhi 11028 New Delhi, IN 110028 |
| Contact | Vivek Narang |
| Correspondent | Vivek Narang Narang Medical Limited 46, Naraina Industriall Area, Phase 1 New Delhi, IN 110028 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-06 |
| Decision Date | 2015-11-25 |
| Summary: | summary |