Device Classification Name |
neurosurgical paddie
|
510(k) Number |
K880402 |
Device Name |
CODMAN SURGICAL PATTIE |
Applicant |
Codman & Shurtleff, Inc. |
41 PACELLA PARK DR. |
RANDOLPH INDUSTRIAL PARK |
RANDOLPH,
MA
02368 -1794
|
|
Applicant Contact |
THOMAS J COURAGE |
Correspondent |
Codman & Shurtleff, Inc. |
41 PACELLA PARK DR. |
RANDOLPH INDUSTRIAL PARK |
RANDOLPH,
MA
02368 -1794
|
|
Correspondent Contact |
THOMAS J COURAGE |
Regulation Number | 882.4700
|
Classification Product Code |
|
Date Received | 01/29/1988 |
Decision Date | 03/02/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|