Device Classification Name |
External Mandibular Fixator And/Or Distractor
|
510(k) Number |
K043555 |
FOIA Releasable 510(k) |
K043555
|
Device Name |
SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR |
Applicant |
SYNTHES (USA) |
P.O. BOX 1766 |
1690 RUSSELL ROAD |
PAOLI,
PA
19301 -1222
|
|
Applicant Contact |
KATHY ANDERSON |
Correspondent |
SYNTHES (USA) |
P.O. BOX 1766 |
1690 RUSSELL ROAD |
PAOLI,
PA
19301 -1222
|
|
Correspondent Contact |
KATHY ANDERSON |
Regulation Number | 872.4760
|
Classification Product Code |
|
Date Received | 12/27/2004 |
Decision Date | 04/12/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|