Device Classification Name |
Mask, Surgical
|
510(k) Number |
K964358 |
Device Name |
AMSEAL SURGICAL FACE MASK |
Applicant |
AMERICAN SEAL CO. |
25029 VIKING ST. |
HAYWARD,
CA
94545
|
|
Applicant Contact |
LISA CHEN |
Correspondent |
AMERICAN SEAL CO. |
25029 VIKING ST. |
HAYWARD,
CA
94545
|
|
Correspondent Contact |
LISA CHEN |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 11/01/1996 |
Decision Date | 02/14/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|