The following data is part of a premarket notification filed by Gpc Medical Limited with the FDA for Gpc Intramedullary Nailing Systems.
| Device ID | K143245 |
| 510k Number | K143245 |
| Device Name: | GPC Intramedullary Nailing Systems |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | GPC MEDICAL LIMITED PLOT NUMBER 8, SHUBH PLAZA M-BLOCK DDA LSC, VIKAS PURI New Delhi, IN 110018 |
| Contact | Vikas Narang |
| Correspondent | Vikas Narang GPC MEDICAL LIMITED PLOT NUMBER 8, SHUBH PLAZA M-BLOCK DDA LSC, VIKAS PURI New Delhi, IN 110018 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-12 |
| Decision Date | 2015-09-30 |
| Summary: | summary |