Device Classification Name |
Drape, Surgical
|
510(k) Number |
K122000 |
Device Name |
HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER |
Applicant |
CHANGZHOU HOLYMED PRODUCTS CO LTD |
528 CHANGWU ROAD SOUTH |
WUJIN DISTRICT |
CHANGHOU,
CN
213167
|
|
Applicant Contact |
ALAN YU |
Correspondent |
CHANGZHOU HOLYMED PRODUCTS CO LTD |
528 CHANGWU ROAD SOUTH |
WUJIN DISTRICT |
CHANGHOU,
CN
213167
|
|
Correspondent Contact |
ALAN YU |
Regulation Number | 878.4370
|
Classification Product Code |
|
Date Received | 07/09/2012 |
Decision Date | 12/12/2012 |
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
|
|
|