Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K981283 |
Device Name |
ROGACHEFSKY DISTAL RADIUS PLATES |
Applicant |
HOWMEDICA, INC. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070
|
|
Applicant Contact |
JOHN DICHIRA |
Correspondent |
HOWMEDICA, INC. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070
|
|
Correspondent Contact |
JOHN DICHIRA |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 04/08/1998 |
Decision Date | 06/10/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|