Device Classification Name |
appliance, fixation, nail/blade/plate combination, multiple component
|
510(k) Number |
K051957 |
Device Name |
REPROCESSED EXTERNAL FIXATION DEVICE |
Applicant |
STERILEMED INC. |
11400 73RD AVE. N. |
MENNEAPOLIS,
MN
55369
|
|
Applicant Contact |
THOMAS A DOLD |
Correspondent |
STERILEMED INC. |
11400 73RD AVE. N. |
MENNEAPOLIS,
MN
55369
|
|
Correspondent Contact |
THOMAS A DOLD |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 07/15/2005 |
Decision Date | 09/21/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|