Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K041786 |
Device Name |
CALCAMEA PLATE |
Applicant |
NEWDEAL S.A. |
9109 COPENHAVER DR. |
POTOMAC,
MD
20854
|
|
Applicant Contact |
NORMA F ESTRIN |
Correspondent |
NEWDEAL S.A. |
9109 COPENHAVER DR. |
POTOMAC,
MD
20854
|
|
Correspondent Contact |
NORMA F ESTRIN |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 07/01/2004 |
Decision Date | 09/08/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|