Device Classification Name |
Surgeon'S Gloves
|
510(k) Number |
K031130 |
Device Name |
YA MEI FIRST AID KIT |
Applicant |
YA MEI TECHNOLOGY CO., LTD. |
13 RED FOX LN. |
LITTLETON,
CO
80127
|
|
Applicant Contact |
Kevin Walls |
Correspondent |
YA MEI TECHNOLOGY CO., LTD. |
13 RED FOX LN. |
LITTLETON,
CO
80127
|
|
Correspondent Contact |
Kevin Walls |
Regulation Number | 878.4460
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/09/2003 |
Decision Date | 06/27/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|