The following data is part of a premarket notification filed by Dsm Biomedical with the FDA for Dsm Biomedical Dpr Cable.
Device ID | K143716 |
510k Number | K143716 |
Device Name: | DSM Biomedical DPR Cable |
Classification | Cerclage, Fixation |
Applicant | DSM BIOMEDICAL 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
Contact | Lori Burns |
Correspondent | Tom Maguire DSM BIOMEDICAL 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
Product Code | JDQ |
CFR Regulation Number | 888.3010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-12-29 |
Decision Date | 2015-10-29 |
Summary: | summary |