Device Classification Name |
Component, Traction, Invasive
|
510(k) Number |
K792561 |
Device Name |
MINI-H-FIXATION |
Applicant |
GENY MEDICAL, INC. |
66 ARGONAUT # 170 |
ALISO VIEJO,
CA
92656
|
|
Correspondent |
GENY MEDICAL, INC. |
66 ARGONAUT # 170 |
ALISO VIEJO,
CA
92656
|
|
Regulation Number | 888.3040 |
Classification Product Code |
|
Date Received | 12/12/1979 |
Decision Date | 12/19/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|