Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K091609 |
Device Name |
NEWDEAL COMPRESSION PLATE |
Applicant |
NEWDEAL SAS |
311 ENTERPRISE DR. |
PLAINSBORO,
NJ
08536
|
|
Applicant Contact |
JUDITH E O'GRADY |
Correspondent |
NEWDEAL SAS |
311 ENTERPRISE DR. |
PLAINSBORO,
NJ
08536
|
|
Correspondent Contact |
JUDITH E O'GRADY |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 06/03/2009 |
Decision Date | 06/30/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|