The following data is part of a premarket notification filed by Kls Martin L.p. with the FDA for Kls Martin Recon Talon.
Device ID | K122860 |
510k Number | K122860 |
Device Name: | KLS MARTIN RECON TALON |
Classification | Plate, Fixation, Bone |
Applicant | KLS MARTIN L.P. 11201 SAINT JOHNS INDUSTRIAL PARKWAY SOUTH Jacksonville, FL 32246 |
Contact | Jennifer Damato |
Correspondent | Jennifer Damato KLS MARTIN L.P. 11201 SAINT JOHNS INDUSTRIAL PARKWAY SOUTH Jacksonville, FL 32246 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-09-18 |
Decision Date | 2012-11-14 |
Summary: | summary |