Device Classification Name |
drape, surgical
|
510(k) Number |
K923960 |
Device Name |
UPPER EXTERMITY DRAPE KIT |
Applicant |
MEDIKMARK, INC. |
333 WEST WACKER DR. |
SUITE 2600 |
CHICAGO,
IL
60606
|
|
Applicant Contact |
RICHARD O WOOD |
Correspondent |
MEDIKMARK, INC. |
333 WEST WACKER DR. |
SUITE 2600 |
CHICAGO,
IL
60606
|
|
Correspondent Contact |
RICHARD O WOOD |
Regulation Number | 878.4370
|
Classification Product Code |
|
Date Received | 08/06/1992 |
Decision Date | 10/07/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|