Device Classification Name |
Blade, Saw, Surgical, Cardiovascular
|
510(k) Number |
K904352 |
Device Name |
CODMAN COLLINS RADIOPARENT STERNAL BLADES |
Applicant |
Codman & Shurtleff, Inc. |
41 PACELLA PARK DR. |
RANDOLPH INDUSTRIAL PARK |
RANDOLPH,
MA
02368 -1794
|
|
Applicant Contact |
JEANETTE CLOUTIER |
Correspondent |
Codman & Shurtleff, Inc. |
41 PACELLA PARK DR. |
RANDOLPH INDUSTRIAL PARK |
RANDOLPH,
MA
02368 -1794
|
|
Correspondent Contact |
JEANETTE CLOUTIER |
Regulation Number | 878.4820
|
Classification Product Code |
|
Date Received | 09/24/1990 |
Decision Date | 11/21/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|