Device Classification Name |
External Mandibular Fixator And/Or Distractor
|
510(k) Number |
K072764 |
Device Name |
KLS MARTIN XTERNAL FIXATOR |
Applicant |
KLS MARTIN L.P. |
11239 ST. JOHNS INDUSTRIAL |
PARKWAY SOUTH |
JACKSONVILLE,
FL
32246
|
|
Applicant Contact |
TOM FAUCETT |
Correspondent |
KLS MARTIN L.P. |
11239 ST. JOHNS INDUSTRIAL |
PARKWAY SOUTH |
JACKSONVILLE,
FL
32246
|
|
Correspondent Contact |
TOM FAUCETT |
Regulation Number | 872.4760
|
Classification Product Code |
|
Date Received | 09/28/2007 |
Decision Date | 12/20/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|