The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Kls-martin Sternal Plating System.
Device ID | K032413 |
510k Number | K032413 |
Device Name: | KLS-MARTIN STERNAL PLATING SYSTEM |
Classification | Plate, Fixation, Bone |
Applicant | KLS-MARTIN L.P. 11239-1 ST. JOHN'S IND. PKWY. SOUTH Jacksonville, FL 32246 |
Contact | Jennifer Damato |
Correspondent | Jennifer 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 | 2003-08-05 |
Decision Date | 2003-10-10 |
Summary: | summary |