Device Classification Name |
gauze/sponge, internal, x-ray detectable
|
510(k) Number |
K905135 |
Device Name |
LAPAROTOMY SPONGES |
Applicant |
AMERICAN HEALTHCARE CORP. |
30 CRAIG ST. |
BRANTFORD, ONTARIO N3T 5M9 |
CANADA,
CA
|
|
Applicant Contact |
CAROL MASON |
Correspondent |
AMERICAN HEALTHCARE CORP. |
30 CRAIG ST. |
BRANTFORD, ONTARIO N3T 5M9 |
CANADA,
CA
|
|
Correspondent Contact |
CAROL MASON |
Regulation Number | 878.4450
|
Classification Product Code |
|
Date Received | 11/15/1990 |
Decision Date | 03/06/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|