Device Classification Name |
drape, surgical
|
510(k) Number |
K121919 |
Device Name |
SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV |
Applicant |
EXACT MEDICAL MANUFACTURING, INC |
1083 DELAWARE AVE |
BUFFALO,
NY
14209
|
|
Applicant Contact |
ROBERT O DEAN |
Correspondent |
EXACT MEDICAL MANUFACTURING, INC |
1083 DELAWARE AVE |
BUFFALO,
NY
14209
|
|
Correspondent Contact |
ROBERT O DEAN |
Regulation Number | 878.4370
|
Classification Product Code |
|
Date Received | 07/02/2012 |
Decision Date | 02/14/2013 |
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
|
|
|