The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Kls Martin Sternal Talon.
Device ID | K051165 |
510k Number | K051165 |
Device Name: | KLS MARTIN STERNAL TALON |
Classification | Plate, Fixation, Bone |
Applicant | KLS-MARTIN L.P. 11239-1 ST. JOHN'S IND. PKWY. SOUTH Jacksonville, FL 32246 |
Contact | Jennijer Damato |
Correspondent | Jennijer Damato KLS-MARTIN L.P. 11239-1 ST. JOHN'S IND. PKWY. 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 | 2005-05-05 |
Decision Date | 2006-09-07 |
Summary: | summary |