Device Classification Name |
External Mandibular Fixator And/Or Distractor
|
510(k) Number |
K060138 |
Device Name |
SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM |
Applicant |
SYNTHES (USA) |
1301 GOSHEN PKWY. |
WEST CHESTER,
PA
19380
|
|
Applicant Contact |
SHERI L MUSGNUNG |
Correspondent |
SYNTHES (USA) |
1301 GOSHEN PKWY. |
WEST CHESTER,
PA
19380
|
|
Correspondent Contact |
SHERI L MUSGNUNG |
Regulation Number | 872.4760
|
Classification Product Code |
|
Date Received | 01/19/2006 |
Decision Date | 06/02/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|