Device Classification Name |
gown, surgical
|
510(k) Number |
K023167 |
Device Name |
BREATHABLE SURGICAL GOWN |
Applicant |
ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD. MPWM-1E |
MCGAW PARK,
IL
60085
|
|
Applicant Contact |
SHARON NICHOLS |
Correspondent |
ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD. MPWM-1E |
MCGAW PARK,
IL
60085
|
|
Correspondent Contact |
SHARON NICHOLS |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 09/23/2002 |
Decision Date | 10/02/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|