Device Classification Name |
dermatome
|
510(k) Number |
K945594 |
Device Name |
DECA DERMATOME (MICROMOTOR SYSTEM) |
Applicant |
DEPUY INTL., LTD. |
ST ANTHONY'S ROAD |
LEEDS, LS 11 8DT |
WEST YORKSHIRE,
GB
LS11 8DT
|
|
Applicant Contact |
IAN WATERHOUSE |
Correspondent |
DEPUY INTL., LTD. |
ST ANTHONY'S ROAD |
LEEDS, LS 11 8DT |
WEST YORKSHIRE,
GB
LS11 8DT
|
|
Correspondent Contact |
IAN WATERHOUSE |
Regulation Number | 878.4820
|
Classification Product Code |
|
Date Received | 11/14/1994 |
Decision Date | 06/05/1995 |
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
|
|
|