Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K090440 |
Device Name |
HINGE PEDIATRIC PLATING SYSTEM |
Applicant |
PEGA MEDICAL INC. |
1105 AUTOROUTE CHOMEDEY |
LAVAL, QUEBEC,
CA
H7W 5J8
|
|
Applicant Contact |
ARIEL DUJOVNE |
Correspondent |
PEGA MEDICAL INC. |
1105 AUTOROUTE CHOMEDEY |
LAVAL, QUEBEC,
CA
H7W 5J8
|
|
Correspondent Contact |
ARIEL DUJOVNE |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/20/2009 |
Decision Date | 05/20/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|