Device Classification Name |
Rod, Fixation, Intramedullary And Accessories
|
510(k) Number |
K041393 |
Device Name |
FASSIER-DUVAL TELSCOPIC IM SYSTEM |
Applicant |
PEGA MEDICAL INC. |
9260 BOUL. VIAU |
MONTREAL (QUEBEC),
CA
H1R 2V8
|
|
Applicant Contact |
ARIEL R DUJOVNE |
Correspondent |
PEGA MEDICAL INC. |
9260 BOUL. VIAU |
MONTREAL (QUEBEC),
CA
H1R 2V8
|
|
Correspondent Contact |
ARIEL R DUJOVNE |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 05/24/2004 |
Decision Date | 08/17/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|