Device Classification Name |
Motor, Surgical Instrument, Pneumatic Powered
|
510(k) Number |
K955174 |
Device Name |
SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY |
Applicant |
SODEM DIFFUSION SA |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Applicant Contact |
ROSINA ROBINSON |
Correspondent |
SODEM DIFFUSION SA |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Correspondent Contact |
ROSINA ROBINSON |
Regulation Number | 878.4820
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/13/1995 |
Decision Date | 01/22/1996 |
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
|