510(k) K143716

DSM Biomedical DPR Cable by Dsm Biomedical — Product Code JDQ

K143716 is an FDA 510(k) premarket notification submitted by Dsm Biomedical for the device "DSM Biomedical DPR Cable". The FDA issued a decision of Substantially Equivalent on October 29, 2015. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. Dsm Biomedical has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2015
Date Received
December 29, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cerclage, Fixation
Device Class
Class II
Regulation Number
888.3010
Review Panel
OR
Submission Type