510(k) Premarket Notification Database
Device Classification Name |
plate, fixation, bone
|
510(k) Number | K961485 |
Device Name | FOREFOOT RECONSTRUCTION SYSTEM |
Applicant |
HOWMEDICA CORP.
|
359 veterans blvd. |
rutherford,
NJ
07070 |
|
Contact | john dichiara |
Regulation Number | 888.3030 |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/18/1996 |
Decision Date | 06/01/1996 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Orthopedic
|
Review Advisory Committee |
Orthopedic
|
Statement/Summary/Purged Status |
Summary only
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
No
|
|
|