Device Classification Name |
Table And Attachments, Operating-Room
|
510(k) Number |
K860177 |
Device Name |
ALLEN UNIVERSAL STIRRUP |
Applicant |
EDGEWATER MEDICAL EQUIPMENT SYSTEMS |
6263 MAYFIELD RD. |
SUITE 206 |
MAYFIELD HTS.,
OH
44124
|
|
Applicant Contact |
DANIEL ALLEN |
Correspondent |
EDGEWATER MEDICAL EQUIPMENT SYSTEMS |
6263 MAYFIELD RD. |
SUITE 206 |
MAYFIELD HTS.,
OH
44124
|
|
Correspondent Contact |
DANIEL ALLEN |
Regulation Number | 878.4950
|
Classification Product Code |
|
Date Received | 01/17/1986 |
Decision Date | 02/11/1986 |
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
|