The following data is part of a premarket notification filed by Kls Martin Lp with the FDA for Kls Martin L1 Mmf System.
Device ID | K173320 |
510k Number | K173320 |
Device Name: | KLS Martin L1 MMF System |
Classification | Plate, Bone |
Applicant | KLS Martin LP 11201 Saint Johns Industrial Parkway S Jacksonville, FL 32246 |
Contact | Jennifer Damato |
Correspondent | Gary Moore KLS Martin LP 11201 Saint Johns Industrial Parkway S Jacksonville, FL 32246 |
Product Code | JEY |
CFR Regulation Number | 872.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-10-20 |
Decision Date | 2018-02-23 |
Summary: | summary |