Device Classification Name |
Mask, Surgical
|
510(k) Number |
K122717 |
Device Name |
FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK |
Applicant |
TIGER MEDICAL PRODUCTS LTD |
1 HUAIHAI ZHONG ROAD |
LIU LIN TOWER, SUITE 1910 |
SHANGHAI,
CN
200021
|
|
Applicant Contact |
DAVID WANG |
Correspondent |
TIGER MEDICAL PRODUCTS LTD |
1 HUAIHAI ZHONG ROAD |
LIU LIN TOWER, SUITE 1910 |
SHANGHAI,
CN
200021
|
|
Correspondent Contact |
DAVID WANG |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 09/05/2012 |
Decision Date | 12/21/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|