Device Classification Name |
Board, Arm (With Cover), Sterile
|
510(k) Number |
K884838 |
Device Name |
ALLEN PRONE ARMBOARD |
Applicant |
EDGEWATER MEDICAL SYSTEMS, INC. |
6263 MAYFIELD RD #206 |
MAYFIELD HTS.,
OH
44124
|
|
Applicant Contact |
DANIEL ALLEN |
Correspondent |
EDGEWATER MEDICAL SYSTEMS, INC. |
6263 MAYFIELD RD #206 |
MAYFIELD HTS.,
OH
44124
|
|
Correspondent Contact |
DANIEL ALLEN |
Regulation Number | 878.3910
|
Classification Product Code |
|
Date Received | 11/21/1988 |
Decision Date | 12/15/1988 |
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
|
|
|