The following data is part of a premarket notification filed by Gpc Medical Ltd with the FDA for Gpc Brand Locking Bone Plates And Screws Osteosynthesis Plating System..
| Device ID | K153716 |
| 510k Number | K153716 |
| Device Name: | GPC BRAND Locking Bone Plates And Screws Osteosynthesis Plating System. |
| Classification | Plate, Fixation, Bone |
| Applicant | GPC MEDICAL LTD M-BLOCK, DDA LSC, VIKAS PURI, New Delhi, IN 110018 |
| Contact | Vikas Narang |
| Correspondent | Vikas Narang GPC MEDICAL LTD M-BLOCK, DDA LSC, VIKAS PURI, New Delhi, IN 110018 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-24 |
| Decision Date | 2016-05-17 |
| Summary: | summary |