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 |