Device Classification Name |
splint, extremity, inflatable, external
|
510(k) Number |
K881516 |
Device Name |
COMPRESAID |
Applicant |
R. EVANS CORP. |
SUITE 209 |
14040 N. CAVE CREEK RD. |
PHOENIX,
AZ
85022
|
|
Applicant Contact |
ROBERT J EVANS |
Correspondent |
R. EVANS CORP. |
SUITE 209 |
14040 N. CAVE CREEK RD. |
PHOENIX,
AZ
85022
|
|
Correspondent Contact |
ROBERT J EVANS |
Regulation Number | 878.3900
|
Classification Product Code |
|
Date Received | 04/11/1988 |
Decision Date | 04/29/1988 |
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
|
|
|