Device Classification Name |
drape, surgical
|
510(k) Number |
K133080 |
Device Name |
Plus Surgical Drapes (EO Sterilized), PMDB-XXX |
Applicant |
FOSHAN NANHAI PLUS MEDICAL CO., LTD. |
3500 SOUTH DUPONT HIGHWAY |
DOVER,
DE
19901
|
|
Applicant Contact |
LEON LU |
Correspondent |
FOSHAN NANHAI PLUS MEDICAL CO., LTD. |
3500 SOUTH DUPONT HIGHWAY |
DOVER,
DE
19901
|
|
Correspondent Contact |
LEON LU |
Regulation Number | 878.4370
|
Classification Product Code |
|
Date Received | 09/30/2013 |
Decision Date | 06/24/2015 |
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
|
|
|