The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for Depuy Synthes Craniomaxillofacial Sternal Devices - Mr Conditional.
Device ID | K190963 |
510k Number | K190963 |
Device Name: | DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional |
Classification | Plate, Fixation, Bone |
Applicant | Synthes (USA) Products LLC 1301 Goshen Parkway West Chester, PA 19380 |
Contact | Jeffrey Krawiec |
Correspondent | Jeffrey Krawiec Synthes (USA) Products LLC 1301 Goshen Parkway West Chester, PA 19380 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-04-12 |
Decision Date | 2019-07-23 |
Summary: | summary |