Device Classification Name |
gown, surgical
|
510(k) Number |
K230838 |
Device Name |
Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets |
Applicant |
Cardinal Health 200, LLC |
3651 Birchwood Drive |
Waukegan,
IL
60085
|
|
Applicant Contact |
Emily Hunter |
Correspondent |
Cardinal Health 200, LLC |
3651 Birchwood Drive |
Waukegan,
IL
60085
|
|
Correspondent Contact |
Emily Hunter |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 03/27/2023 |
Decision Date | 07/27/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|