The following data is part of a premarket notification filed by Gpc Medical Ltd with the FDA for Gpc Bone Plaes And Bone Screw & Gpc Dhs/dcs Plate System.
| Device ID | K092493 |
| 510k Number | K092493 |
| Device Name: | GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE 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 |
| Subsequent Product Code | HWC |
| Subsequent Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-14 |
| Decision Date | 2010-03-29 |
| Summary: | summary |