Device Classification Name |
plate, bone
|
510(k) Number |
K971987 |
Device Name |
SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR |
Applicant |
SYNTHES (USA) |
1690 RUSSELL RD. |
POST OFFICE BOX 1766 |
PAOLI,
PA
19301
|
|
Applicant Contact |
SHERI L MUSGNUNG |
Correspondent |
SYNTHES (USA) |
1690 RUSSELL RD. |
POST OFFICE BOX 1766 |
PAOLI,
PA
19301
|
|
Correspondent Contact |
SHERI L MUSGNUNG |
Regulation Number | 872.4760
|
Classification Product Code |
|
Date Received | 05/29/1997 |
Decision Date | 06/24/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|