Device Classification Name |
drape, surgical
|
510(k) Number |
K140250 |
Device Name |
3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE |
Applicant |
3M HEALTH CARE |
3M CENTER, 2510 CONWAY AVE. |
BLDG 275-5W-06 |
ST. PAUL,
MN
55144
|
|
Applicant Contact |
KRISTIN TOTUSHEK |
Correspondent |
3M HEALTH CARE |
3M CENTER, 2510 CONWAY AVE. |
BLDG 275-5W-06 |
ST. PAUL,
MN
55144
|
|
Correspondent Contact |
KRISTIN TOTUSHEK |
Regulation Number | 878.4370
|
Classification Product Code |
|
Date Received | 01/31/2014 |
Decision Date | 07/25/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|