Device Classification Name |
Drape, Surgical
|
510(k) Number |
K000417 |
Device Name |
CONVERTORS EQUIPMENT DRAPES |
Applicant |
ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD.- K |
MCGRAW PARK,
IL
60085
|
|
Applicant Contact |
SHARON ROBBINS |
Correspondent |
ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD.- K |
MCGRAW PARK,
IL
60085
|
|
Correspondent Contact |
SHARON ROBBINS |
Regulation Number | 878.4370
|
Classification Product Code |
|
Date Received | 02/08/2000 |
Decision Date | 03/17/2000 |
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
|
|
|