Device Classification Name |
Mask, Surgical
|
510(k) Number |
K043199 |
Device Name |
SURGICAL FACE MASK |
Applicant |
HONG YA NON-WOVEN PRODUCTS CO., LTD. |
3973 SCHAEFER AVE. |
CHINO,
CA
91710
|
|
Applicant Contact |
JAMES CHU |
Correspondent |
HONG YA NON-WOVEN PRODUCTS CO., LTD. |
3973 SCHAEFER AVE. |
CHINO,
CA
91710
|
|
Correspondent Contact |
JAMES CHU |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 11/18/2004 |
Decision Date | 02/16/2005 |
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
|
|
|